This page shows what was measured, who it was measured in, and what that does not settle.
What Raltegravir does in the body
HIV-1 infection, as part of a combination regimen
HIV cannot stay in a cell as a loose copy. It has to cut into a chromosome and paste itself in, and integrase is the tool that does the cutting. That tool works by holding two magnesium atoms in place and using them to make the cut. Raltegravir grabs both magnesium atoms, so the enzyme is holding the drug instead of the DNA and the paste step never happens. Virus already pasted in before treatment is untouched, which is why this suppresses rather than cures.
What happened in people
62.1% against 32.9% below 50 copies per millilitre at week 48 in 699 triple-class-resistant patients (p<0.001)
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
The limit that matters most
That the raw cancer proportions of 3.5% against 1.7% in BENCHMRK described a real excess risk, when person-time differed substantially between arms and the imbalance did not persist
Where it acts
HIV-1 intasome, in the cytoplasm and nucleus of infected CD4-positive T cells
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 43Y000U234 · read 2026-08-29
Its recorded molecular formula is C20H20FKN6O5, weighing 482.51.
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 115 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Cholesterol
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved5 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Cholesterol
fasting serum cholesterol at week 12; non high density lipoprotein cholesterol at week 12; fasting serum low density lipoprotein cholesterol at week 12; serum triglyceride at week 12; triglycerides
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
5 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Proportion with HIV-1 RNA below 400 copies per millilitre at week 16 in triple-class-resistant patients, with optimised background therapy in both arms
✓ The study showed what it set out to show
Who was studied
BENCHMRK-1 and -2 (NCT00293267, NCT00293254)
How many people
699
Study design
Two identical phase 3, randomised 2:1, double-blind, placebo-controlled trials
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
77.5% versus 41.9% below 400 copies per millilitre at week 16 (p<0.001); 62.1% versus 32.9% below 50 copies per millilitre at week 48 (p<0.001)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Cancers were detected in 3.5% of raltegravir recipients against 1.7% on placebo without adjustment for length of follow-up, in arms of very different size and retention. The imbalance did not persist and there is no malignancy warning in the labelling.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet in two strengths with different dissolution, chewable tablet, and granules for oral suspension for neonates
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
83% versus 89%, difference -5.7% (95% CI -10.7 to -0.83, p=0.044); the lower bound crossed the -10% non-inferiority margin
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. This is a manufacturer-funded trial of a manufacturer-preferred dosing schedule that reported its own negative result and concluded in print that the schedule cannot be recommended. It is on this page as an example of the thing working.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet in two strengths with different dissolution, chewable tablet, and granules for oral suspension for neonates
Interval reported. 95% CI -10
Written into the record, not signed off as a reviewed claim.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
Proportion with HIV-1 RNA below 40 copies per millilitre at week 48 by FDA snapshot, raltegravir 1200 mg once daily as reformulated tablets against 400 mg twice daily
89% versus 88%, treatment difference 0.5% (95% CI -4.2 to 5.2)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The successful once-daily regimen uses a 50% higher total daily dose in a differently formulated tablet. It is not the regimen QDMRK tested and failed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet in two strengths with different dissolution, chewable tablet, and granules for oral suspension for neonates
Interval reported. 95% CI -4
Written into the record, not signed off as a reviewed claim.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.6 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Raltegravir
What a person takes: Oral film-coated tablet in two strengths with different dissolution, chewable tablet, and granules for oral suspension for neonates.
The measurement behind this step
The 400 mg tablet is taken twice daily; the reformulated 600 mg tablet is taken once daily as two tablets, and the two are not interchangeable on a milligram-per-milligram basis. Chewable tablets and granules for suspension are not interchangeable with the film-coated tablets either, because their bioavailability differs. Polyvalent cations chelate the same triad the drug uses on magnesium, so antacids interfere by binding the drug rather than by any effect on the gut.
Getting in
Swallowed twice a day in the original tablet, once in the reformulated one
The original tablet has to be taken every twelve hours. A newer, differently made tablet dissolves better and can be taken once a day. Same molecule, different tablet.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Raltegravir has a short plasma half-life of around 9 hours and its absorption is formulation-dependent. Two 400 mg tablets taken together once daily failed non-inferiority in QDMRK; two reformulated 600 mg tablets taken together once daily met it in ONCEMRK, with the improved bioavailability attributed at least in part to differences in tablet dissolution. Elimination is by UGT1A1 glucuronidation with no cytochrome P450 involvement, so no booster is needed and the interaction profile is dominated by UGT inducers such as rifampicin.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
Reaching the cell
It sits inside the cell waiting for the virus to arrive
The drug moves into cells by itself and does nothing until a virus enters, copies its genome into DNA and assembles the machine that will paste that DNA in.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Raltegravir is passively permeable and requires no intracellular activation, unlike the nucleoside analogues it is combined with, which must be phosphorylated three times before they do anything. It has negligible affinity for free integrase and binds only once the intasome, the nucleoprotein complex of integrase tetramer with viral DNA ends, has assembled.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
What it acts on
It grabs the two magnesium atoms the cutting enzyme needs
Integrase works by holding two magnesium atoms and using them to make a chemical cut. Raltegravir clamps onto both, so the enzyme is now gripping the drug rather than the DNA.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The N-methyl-4-hydroxypyrimidinone carbonyl core presents a coplanar triad of oxygen atoms that chelates both catalytic Mg2+ ions in the integrase active site, and the 4-fluorobenzyl group occupies the pocket the displaced 3-prime adenosine of viral DNA would fill. This was the first pharmacophore of its kind to reach approval and every drug in the class since uses a variant of it.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
The change it makes
The paste step is blocked, but only while the drug stays bound
Strand transfer stops. The catch is how long the drug holds on: raltegravir lets go within minutes, so an enzyme that has been slightly reshaped by a mutation can still get its work done between visits.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Strand transfer is blocked specifically; 3-prime processing, the earlier step in which integrase trims a GT dinucleotide from each viral DNA end, still occurs. Dissociation from the intasome is on a minute timescale, against hours for dolutegravir. Three independent primary resistance pathways, Y143, Q148 and N155, each reduce binding enough to restore function, which is why 64 of 94 genotyped BENCHMRK failures carried treatment-emergent integrase mutations.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
What that does for a person
Viral load falls faster than on anything before it, and stays down if it holds
Virus drops quickly, faster than with the drugs it was compared against. It stays down for years in most people. When it does not, the failure usually costs the whole class.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Time to suppression was significantly shorter than on efavirenz in STARTMRK (log-rank p<0.0001), and five-year suppression was 71.0% against 61.3%. Unintegrated viral DNA is circularised and lost through cell division. Integrated provirus present before treatment is untouched, which is why this is suppression rather than cure. Failure with Y143, Q148 or N155 substitutions removes raltegravir and elvitegravir and reduces the options within the class for later drugs.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
fasting serum cholesterol at week 12
non high density lipoprotein cholesterol at week 12
fasting serum low density lipoprotein cholesterol at week 12
serum triglyceride at week 12
triglycerides
flow mediated dilation of the brachial artery
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (34)
treatment response at week 48
clinical adverse experiences through 24 weeks
who died
pharmacokinetic parameter area under the curve
safety assessments
pharmacokinetic assessments
treatment failure
hiv infected cells
neuropsychological performance change
cd4 cell counts
time to confirmed virologic failure
time to virologic failure
time from randomization to virologic failure
one or more adverse events
cumulative probability of first virologic failure by week 96
reaching virologic failure at week 48
viral load
primary objective
hcv rna
hiv 1 rna level 40 c/ at week 24
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
People with multidrug-resistant HIV-1, newborns and very small infants for whom it has the widest paediatric licence in the class, and people in whom drug interactions rule out other integrase inhibitors, since raltegravir is not metabolised by cytochrome P450 at all.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “HIV-1 Infected Children The safety, tolerability, pharmacokinetic profile, and efficacy of twice daily raltegravir were evaluated in HIV-1 infected infants, children and adolescents 4 weeks to 18 years of age in an open-label, multicenter clinical trial, IMPAACT P1066 [see Dosage and Administration (2.3) , Clinical Pharmacology (12.3) and Clinical Studies (14.4)].”
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-30
On older people, the label states: “Clinical studies of raltegravir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women.”
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.”
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-30
Where the result stopped carrying
QDMRK missed its non-inferiority margin and the sponsor published the conclusion that once-daily raltegravir could not be recommended in place of twice-daily dosing
Treatment-emergent integrase resistance arose in 64 of 94 genotyped BENCHMRK failures, 75% of them with two or more mutations, across three independent escape pathways
Directly against dolutegravir in SAILING, raltegravir produced seventeen emergent-resistance failures against four
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral film-coated tablet in two strengths with different dissolution, chewable tablet, and granules for oral suspension for neonates
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
The 400 mg tablet is taken twice daily; the reformulated 600 mg tablet is taken once daily as two tablets, and the two are not interchangeable on a milligram-per-milligram basis. Chewable tablets and granules for suspension are not interchangeable with the film-coated tablets either, because their bioavailability differs. Polyvalent cations chelate the same triad the drug uses on magnesium, so antacids interfere by binding the drug rather than by any effect on the gut.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Severe and potentially life-threatening skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms are labelled. Creatine kinase elevation, myopathy and rhabdomyolysis have been reported. Immune reconstitution inflammatory syndrome can follow suppression. Overall drug-related adverse events ran at roughly half the efavirenz rate in the head-to-head trial, and neuropsychiatric effects at 39.1% against 64.2% over five years. The cancer imbalance reported in the registration trial is discussed in the audits and did not persist.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced … · a recorded source, not a stored snapshot
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Raltegravir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1570 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
virologic failure — 307 reaction mentions
drug interaction — 202 reaction mentions
depression — 187 reaction mentions
drug resistance — 143 reaction mentions
pathogen resistance — 143 reaction mentions
premature baby — 134 reaction mentions
viral mutation identified — 134 reaction mentions
lipodystrophy acquired — 114 reaction mentions
abortion spontaneous — 111 reaction mentions
drug reaction with eosinophilia and systemic symptoms — 95 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral film-coated tablet in two strengths with different dissolution, chewable tablet, and granules for oral suspension for neonates
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Chewable tablets and granules for suspension are not interchangeable with the film-coated tablets either, because their bioavailability differs. Polyvalent cations chelate the same triad the drug uses on magnesium, so antacids interfere by binding the drug rather than by any effect on the gut.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
22 products list this as an active ingredient in the United States drug directory. 22 of them contain it and nothing else.
FDA National Drug Code directory · 50473-0001 · read 2026-08-29
They are sold as granule, for suspension, powder, tablet, chewable and tablet, film coated, taken oral.
FDA National Drug Code directory · 50473-0001 · read 2026-08-29
The regulator's established pharmacologic class for it is hiv integrase inhibitors [moa] and human immunodeficiency virus integrase strand transfer inhibitor [epc].
FDA National Drug Code directory · 50473-0001 · read 2026-08-29
5 published labels name it as an active ingredient. 5 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-29
Raltegravir is oral at 3 DOSAGE FORMS AND STRENGTHS Raltegravir Tablets USP, 400 mg: White to off-white oval shaped film coated tablets debossed with “H I” on one side and “4” on other side of the tablet. • Film-Coated Tablets: 400 mg ( 3 )., recorded as fda label in effect 2026-07-04 in the United States.
US prescribing information · 090aa265-9fc8-4aea-81fe-ce052c3f38df · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Raltegravir studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the raw cancer proportions of 3.5% against 1.7% in BENCHMRK described a real excess risk, when person-time differed substantially between arms and the imbalance did not persist
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That once-daily dosing was the property that failed in QDMRK, when the successful regimen changed both the formulation and the total daily dose
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That pharmacokinetic modelling of trough concentrations predicts virological outcome for this drug, which is the assumption QDMRK was designed on and disproved
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Raltegravir are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
BENCHMRK: 62% suppressed against 33% in triple-class-resistant patients
In plain words
In 699 people whose virus had already defeated all three existing drug classes, adding raltegravir to the best remaining regimen put 62% below 50 copies per millilitre at 48 weeks against 33% on the best remaining regimen alone. For that population there had previously been nothing new to add.
What was measured
Proportion with HIV-1 RNA below 50 copies per millilitre at weeks 16 and 48, non-completion counted as failure
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
BENCHMRK-1 and BENCHMRK-2 (NCT00293267 and NCT00293254) were two identical double-blind trials in different regions, randomising patients with triple-class drug-resistant HIV-1 failing therapy 2:1 to raltegravir 400 mg twice daily or placebo, each with an optimised background regimen; 699 of 703 randomised patients received study drug, 462 raltegravir and 237 placebo. At week 16, counting non-completion as failure, 355 of 458 (77.5%) against 99 of 236 (41.9%) had HIV-1 RNA below 400 copies per millilitre (p<0.001). Below 50 copies per millilitre the figures were 61.8% against 34.7% at week 16 and 62.1% against 32.9% at week 48 (p<0.001 for both). Superiority was consistent across every prognostic subgroup examined, including high baseline viral load, low CD4 count and low genotypic or phenotypic sensitivity score. Among patients using both darunavir and enfuvirtide for the first time, 89% of raltegravir recipients against 68% of placebo recipients reached below 50 copies per millilitre.
Written into the record, not signed off as a reviewed claim
STARTMRK: matched efavirenz at 48 weeks and beat it at five years
In plain words
Against efavirenz in 566 people starting treatment, raltegravir reached 86% suppressed against 82% at 48 weeks, and drove viral load down faster. By five years the gap had widened to 71% against 61%, largely because far fewer people had stopped taking it.
What was measured
Proportion below 50 copies per millilitre at week 48 (difference 4.2%, 95% CI -1.9 to 10.3) and at week 240 (difference 9.5%, 95% CI 1.7 to 17.3)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
STARTMRK (NCT00369941) randomised 566 treatment-naive patients, double-blind, to raltegravir 400 mg twice daily or efavirenz 600 mg once daily, each with tenofovir disoproxil and emtricitabine, and remained blinded to its five-year conclusion. At baseline 297 (53%) had above 100,000 copies per millilitre and 267 (47%) had CD4 counts at or below 200 cells per microlitre. At week 48, with non-completion counted as failure, 241 of 281 (86.1%) against 230 of 282 (81.9%) reached below 50 copies per millilitre, difference 4.2% (95% CI -1.9 to 10.3) against a 12% non-inferiority margin, with a significantly shorter time to suppression (log-rank p<0.0001). Drug-related clinical adverse events occurred in 124 (44.1%) against 217 (77.0%), difference -32.8% (95% CI -40.2 to -25.0, p<0.0001). At week 240, 198 of 279 (71.0%) against 171 of 279 (61.3%) were below 50 copies per millilitre, difference 9.5% (95% CI 1.7 to 17.3). Discontinuation for adverse events was 14 (5%) against 28 (10%), and neuropsychiatric side effects 39.1% against 64.2% (p<0.001).
Written into the record, not signed off as a reviewed claim
QDMRK: the once-daily trial failed, and the sponsor published that it failed
In plain words
Pharmacokinetic modelling said two 400 mg tablets taken together once a day should work as well as one every twelve hours. A 775-patient trial tested it and found 83% suppressed against 89%, missing the non-inferiority margin. The published conclusion was that once-daily raltegravir cannot be recommended.
What was measured
Proportion below 50 copies per millilitre at week 48: 83% against 89%, difference -5.7% (95% CI -10.7 to -0.83) against a -10% margin
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
QDMRK (NCT00745823) was an international, double-blind, phase 3 non-inferiority trial at 83 centres, randomising 775 antiretroviral-naive patients 1:1 to raltegravir 400 mg twice daily or two 400 mg tablets taken together once daily, each with co-formulated tenofovir disoproxil and emtricitabine; 770 received study drug. At baseline 304 (39%) had above 100,000 copies per millilitre and 188 (24%) had CD4 counts below 200 cells per microlitre. At week 48, with non-completers counted as failures, 318 of 382 (83%) once-daily patients against 343 of 386 (89%) twice-daily patients had viral RNA below 50 copies per millilitre, difference -5.7% (95% CI -10.7 to -0.83, p=0.044). The lower bound crossed the prespecified -10% margin, so non-inferiority was not established, and the difference was nominally significant in favour of the established schedule. Serious adverse events were 26 (7%) against 40 (10%). The trial was funded by Merck, and its published interpretation reads, in full: despite high response rates with both regimens, once-daily raltegravir cannot be recommended in place of twice-daily dosing.
Written into the record, not signed off as a reviewed claim
Once-daily then succeeded at a higher total dose in a different tablet, not at the same dose in the same tablet
In plain words
The lesson of the failed trial was read carefully. The problem was not the schedule; it was that the original tablet did not dissolve well enough to sustain a whole day from a single dose. A reformulated tablet, at a higher total daily dose, was then tested and worked.
What was measured
That the original once-daily failure was a schedule problem — it was a formulation and total-dose problem, and reading it as the former would have retired a workable regimen
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ONCEMRK (NCT02131233) randomised 802 treatment-naive patients 2:1, double-blind, at 139 sites, to raltegravir 1200 mg once daily as two 600 mg reformulated tablets or to raltegravir 400 mg twice daily, each with tenofovir disoproxil and emtricitabine; 797 received study therapy. At week 48, 472 of 531 (89%) against 235 of 266 (88%) had HIV-1 RNA below 40 copies per millilitre by FDA snapshot, treatment difference 0.5% (95% CI -4.2 to 5.2) against a -10% margin, and non-inferiority was met. Drug-related adverse events occurred in 130 (24%) against 68 (26%). The 600 mg tablet has improved bioavailability over the 400 mg tablet, attributed at least in part to differences in tablet dissolution. So the sequence is: a dosing schedule fails at 800 mg a day in the old tablet, and succeeds at 1200 mg a day in a new one. Total daily dose rose by half and the formulation changed, and the failed trial is what made the successful one possible.
Written into the record, not signed off as a reviewed claim
The lowest resistance barrier in its class, with three separate escape routes
In plain words
Of the patients who failed raltegravir in the resistance trials, most had developed integrase mutations, and three quarters of those had more than one. Against dolutegravir in a head-to-head trial, raltegravir produced four times as many failures carrying new integrase resistance.
What was measured
Treatment-emergent integrase resistance in 64 of 94 genotyped failures, 75% of them carrying two or more mutations; 17 against 4 emergent-resistance failures against dolutegravir
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In BENCHMRK at week 48, 105 of 462 raltegravir recipients (23%) had virological failure. Genotyping was done in 94 of them, and integrase mutations known to confer phenotypic resistance had arisen during treatment in 64 (68%); 48 of those 64 (75%) carried two or more resistance-associated mutations. Escape runs through three independent primary pathways, Y143, Q148 and N155, each with its own secondary mutations, so the virus has more than one route out. In SAILING, which compared raltegravir directly with dolutegravir in 715 treatment-experienced, integrase-naive adults, virological failure with treatment-emergent integrase resistance occurred in seventeen raltegravir patients against four on dolutegravir, adjusted difference -3.7% (95% CI -6.1 to -1.2, p=0.003). The mechanistic account is dissociation kinetics: raltegravir leaves the intasome in minutes, so an integrase carrying a modestly weakened binding site still functions, whereas dolutegravir stays bound for hours and the equivalent mutant loses more fitness than it gains.
Written into the record, not signed off as a reviewed claim
A cancer imbalance in the registration trial that did not survive follow-up
In plain words
The paper that established raltegravir reported cancers in 3.5% of drug recipients against 1.7% on placebo. That number entered the literature unadjusted for how long each group had been followed, and the imbalance did not persist as the trials continued.
What was measured
That the 3.5% against 1.7% raw cancer proportions in BENCHMRK described a real excess risk, when the two arms differed substantially in person-time and the imbalance did not persist
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The BENCHMRK primary publication states that without adjustment for length of follow-up, cancers were detected in 3.5% of raltegravir recipients against 1.7% of placebo recipients. The caveat is doing considerable work: the raltegravir arm was twice the size, retained patients far longer because the drug worked, and the placebo arm was largely lost to failure and rollover, so person-time differed substantially between the two. The week 96 combined analysis of BENCHMRK-1 and -2 reports raltegravir with optimised background as generally well tolerated with superior and durable efficacy, and the signal is not carried forward as a finding. Raltegravir has no malignancy warning in its labelling. This is worth recording precisely because it is the ordinary case: a numerically alarming raw proportion, published honestly with its own caveat attached, that did not become anything.
Written into the record, not signed off as a reviewed claim
The one property no successor took from it: no cytochrome P450 metabolism at all
In plain words
Raltegravir is cleared by a completely different route from almost every other HIV drug, which means it has almost no interactions with the liver enzymes that cause most drug interactions. That is why it is still used in transplant patients, in tuberculosis co-treatment and in the smallest newborns.
What was measured
Elimination by UGT1A1 glucuronidation with no cytochrome P450 substrate, inhibitor or inducer activity, and a paediatric licence down to 2 kg
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Raltegravir is eliminated principally by UGT1A1-mediated glucuronidation and is neither a substrate nor an inhibitor nor an inducer of cytochrome P450 enzymes. It requires no pharmacokinetic booster. The practical consequences are that its interaction list is short and dominated by UGT1A1 inducers such as rifampicin, and that it can be given alongside drug classes whose CYP3A interactions make protease inhibitors and boosted regimens difficult, including immunosuppressants after solid organ transplant and several oncology agents. It also holds the widest paediatric licence in the integrase class, down to neonates weighing at least 2 kg. These are narrow advantages rather than general ones, and they are the reason a drug beaten on efficacy and on resistance barrier by its own successors is still on the market.
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What is not here
4 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
The first integrase strand-transfer inhibitor approved anywhere, which chelates the two magnesium ions integrase needs to splice HIV into human DNA; it suppressed 62% of triple-class-resistant patients below 50 copies per millilitre against 33% on optimised background alone, and matched efavirenz in treatment-naive patients while causing roughly half the drug-related adverse events, but it needs twice-daily dosing in its original tablet and has the lowest resistance barrier in its class.
Recorded evidence blocks (12)
Q1
What did Raltegravir's largest trial (1814 people) and its longest (17 years) measure?
1814 people in Raltegravir's largest registered study, 17 years in its longest registered window, measuring Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment. ClinicalTrials.gov · 2026-09-01
50 phase4, 37 phase1, 36 phase3, 34 phase2, 23 na, 16 na or unstated, 3 early phase1; NCT00042289; 2020-09-30. Last human test completed 2024, NCT03954327.
Interpretation These counts include studies where Raltegravir was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase4
50
phase1
37
phase3
36
phase2
34
na
23
na or unstated
16
2 more recorded rows
early phase1
3
Last recorded human testNCT03954327
2024-01-01
recorded 2026-09-01 · last checked 2026-09-04
Q2
Raltegravir was tested only in human — what did it show?
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment — the recorded outcome words.
Show the evidence
humanNCT01213316
mechanism-only; Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment; 190
recorded 2026-09-01 · last checked 2026-09-04
Q3
18 of Raltegravir's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (4), accrual/recruitment (7), funding/business (2) and other (5): Raltegravir's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir"; 18 of 190 registered studies
Show the evidence
Trial
NCT00443703
terminated; "primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir"
NCT00562510
terminated; "recruitment lower than estimated"
NCT00614458
terminated; "Due to insufficient funds"
NCT00632970
terminated; "no patients completed"
NCT00745823
terminated; "Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily"
NCT00768989
terminated; "Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population."
12 further recorded trials
NCT00781287
terminated; "Enrollment too slow."
NCT01225705
withdrawn; "no pts recruited"
NCT01245101
terminated; "Poor enrollment."
NCT01293123
terminated; "Did not meet enrollment goals"
NCT01448486
terminated; "Funding withdrawn based on unacceptably slow recruitment rate."
NCT01601626
terminated; "The study was stopped early due to feasibility concerns."
NCT01620736
withdrawn; "The clinical trial did not receive any funding."
NCT01854762
terminated; "IRB recommended study termination due to a significant difference between arms"
NCT01902186
terminated; "Low enrollment"
NCT02116660
terminated; "This study was terminated early due to poor recruitment."
NCT02247687
terminated; "Low recruitment of participants for the study"
NCT03333083
terminated; "The reason for the premature termination was the failure to reach the required number of participants."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Raltegravir used Raltegravir oral granules for suspension (20 mg/mL) — over how long?
12 recorded entries; human; oral, orally; also "MK-0518 400mg twice a day", "Comparator: Raltegravir 400 mg b.i.d.", "Experimental: Raltegravir 800 mg q.d."
Show the evidence
human
NCT00485264
oral; Raltegravir oral granules for suspension (20 mg/mL)
NCT00554398
MK-0518 400mg twice a day
NCT00745823
Comparator: Raltegravir 400 mg b.i.d.
NCT00745823
Experimental: Raltegravir 800 mg q.d.
NCT01027182
ISENTRESS, 400mg
NCT01384734
Raltegravir 400 mg
6 more recorded rows
humanNCT01480713
Isentress® (Raltegravir, 400 mg every 12 hours)
humanNCT01978743
Raltegravir (Isentress) 400mg BID
humanNCT02473367
Raltegravir 1200 mg
humanNCT03205566
Raltegravir 400Mg Tab
humanNCT03842488
Raltegravir (RAL) 600mg Oral Tablet
humanNCT04258475
orally; Raltegravir standard dosage of 1200 mg (two 600 mg tablets) orally once daily.
recorded 2026-09-01 · last checked 2026-09-04
Q5
Did Raltegravir move epigenetic age, and by how much?
epigenetic age: "We aimed to investigate a range of epigenetic ageing biomarkers in a substudy of the NEAT001/ANRS143 clinical trial, which compared ritonavir-boosted darunavir with either raltegravir or tenofovir disoproxil fumarate and emtricitabine in antiretroviral therapy (ART)-naive adults." Europe PMC · epigenetic clock search · 2021-04-01
1 recorded sentence; 2021; biomarker
Show the evidence
epigenetic agePMID 33794182
2021; "We aimed to investigate a range of epigenetic ageing biomarkers in a substudy of the NEAT001/ANRS143 clinical trial, which compared ritonavir-boosted darunavir with either raltegravir or tenofovir disoproxil fumarate and emtricitabine in antiretroviral therapy (ART)-naive adults."
recorded 2021-04-01 · last checked 2026-09-04
Q6
Could one person measure Raltegravir's effect on treatment response at week 48?
Treatment response at week 48: measured in Raltegravir's trials.
treatment response at week 48 is the recorded endpoint.
Show the evidence
biomarkers
treatment response at week 48; 2026-09-01
clinical adverse experiences through 24 weeks; 2026-09-01
fasting serum cholesterol at week 12; 2026-09-01
non high density lipoprotein cholesterol at week 12; 2026-09-01
fasting serum low density lipoprotein cholesterol at week 12; 2026-09-01
serum triglyceride at week 12; 2026-09-01
14 more recorded rows
biomarkers
who died; 2026-09-01
biomarkers
pharmacokinetic parameter area under the curve; 2026-09-01
biomarkers
safety assessments; 2026-09-01
biomarkers
pharmacokinetic assessments; 2026-09-01
biomarkers
treatment failure; 2026-09-01
biomarkers
hiv infected cells; 2026-09-01
biomarkers
neuropsychological performance change; 2026-09-01
biomarkers
cd4 cell counts; 2026-09-01
biomarkers
time to confirmed virologic failure; 2026-09-01
biomarkers
time to virologic failure; 2026-09-01
biomarkers
time from randomization to virologic failure; 2026-09-01
biomarkers
one or more adverse events; 2026-09-01
biomarkers
cumulative probability of first virologic failure by week 96; 2026-09-01
biomarkers
reaching virologic failure at week 48; 2026-09-01
half life
2026-09-04; halfLife; 2026-07-13
human trials at or under30
92
smallest human trial
0; NCT00863668; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events, amlodipine auc and amlodipine c24h did Raltegravir's trials measure?
adverse events, amlodipine auc and amlodipine c24h lead 40 outcome terms across Raltegravir's trials. ClinicalTrials.gov · 2026-09-01
non high density lipoprotein cholesterol at week 12, fasting serum low density lipoprotein cholesterol at week 12, serum triglyceride at week 12, who died, pharmacokinetic parameter area under the curve and safety assessments follow.
Show the evidence
treatment response at week 48
1
clinical adverse experiences through 24 weeks
1
fasting serum cholesterol at week 12
1
non high density lipoprotein cholesterol at week 12
1
fasting serum low density lipoprotein cholesterol at week 12
1
serum triglyceride at week 12
1
14 more recorded rows
who died
1
pharmacokinetic parameter area under the curve
1
safety assessments
1
pharmacokinetic assessments
1
treatment failure
1
hiv infected cells
1
neuropsychological performance change
1
cd4 cell counts
1
time to confirmed virologic failure
1
time to virologic failure
1
time from randomization to virologic failure
1
one or more adverse events
1
cumulative probability of first virologic failure by week 96
1
reaching virologic failure at week 48
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Raltegravir's 2 ongoing trials reports first?
Number of participants who achieve HIV remission; The prevalence of AO among different treatment strategies; latest 2031-12-31
Show the evidence
Trial
NCT02140255
"Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission"; n 1120; "Number of participants who achieve HIV remission"; 2031-12-31
NCT07080138
"Research on the Psychological Status of Patients With HIV-1 Infection"; n 500; "The prevalence of AO among different treatment strategies"; 2026-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 59 trials of Raltegravir posted no result?
Posted no result
59 of 59 completed trials
Registrations
NCT00518297, NCT00564772, NCT00618241, NCT00665717, NCT00765271 and NCT00746499, and 53 more
Completion dates
oldest 2007-12; newest 2024-01-01
Show the evidence
Trial
NCT00518297
2007-12
NCT00564772
2007-12
NCT00618241
2008-10
NCT00665717
2008-10
NCT00765271
2008-10
NCT00746499
2008-11
14 further recorded trials
NCT00784420
2008-11
NCT00460382
2009-09
NCT00554398
2009-09
NCT00774683
2009-09
NCT00944307
2009-12
NCT00995241
2009-12
NCT00528892
2010-03
NCT01027182
2010-03
NCT00660972
2010-04
NCT01101893
2010-06
NCT01159132
2010-12
NCT01121809
2011-01
NCT00738569
2011-02
NCT01241773
2011-04
Q10
At the median, Raltegravir's trials enrolled 32 people — anything larger?
Median enrolment
32
Largest enrolment
1814
Registered trials counted
189
Q11
What do 1570 spontaneous reports say about Raltegravir — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Raltegravir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1570 reaction mentions were counted: virologic failure 307; drug interaction 202; depression 187; drug resistance 143. open-targets-adr · CHEMBL254316 · 2026-06-24
Show the evidence
virologic failure
307
drug interaction
202
depression
187
drug resistance
143
pathogen resistance
143
premature baby
134
4 more recorded rows
viral mutation identified
134
lipodystrophy acquired
114
abortion spontaneous
111
drug reaction with eosinophilia and systemic symptoms
95
recorded 2026-06-24 · last checked 2026-09-04
Q12
Raltegravir and CYP1A2, CYP2B6 and CYP3A4: shared by which compounds?
CYP1A2, CYP2B6 and CYP3A4 appear in Raltegravir's recorded interaction sentences, 10 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
Moreover, in vitro , raltegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
pharmacokinetics
Drug Interactions In vitro , raltegravir does not inhibit (IC50>100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A.
CYP2B6
pharmacokinetics
Moreover, in vitro , raltegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
pharmacokinetics
Drug Interactions In vitro , raltegravir does not inhibit (IC50>100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A.
CYP2C19pharmacokinetics
Drug Interactions In vitro , raltegravir does not inhibit (IC50>100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A.
CYP2C8pharmacokinetics
Drug Interactions In vitro , raltegravir does not inhibit (IC50>100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A.
CYP2C9pharmacokinetics
Drug Interactions In vitro , raltegravir does not inhibit (IC50>100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A.
CYP2D6pharmacokinetics
Drug Interactions In vitro , raltegravir does not inhibit (IC50>100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A.
CYP3A4
pharmacokinetics
Moreover, in vitro , raltegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
pharmacokinetics
In vivo , raltegravir does not inhibit CYP3A4.
recorded 2026-08-30 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 11 source rows
✓ no critical contamination: no quarantine open
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✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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