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Drug

Raltegravir

Approved · EMA
Emerging researchLate-stage developmentCooling momentum

Also known as Isentress.

RxNorm719872ChEMBLCHEMBL254316UNII22VKV8053U
14
Research papers
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Clinical trial2026-06-17Results expected Q1 2028 · ClinicalTrials.gov

A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy

Clinical trial2026-03-27Results posted · ClinicalTrials.gov

Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Clinical Trial (NCT02284035)

Clinical trial2025-07-18Results posted · ClinicalTrials.gov

Bone and Body Comp: A Sub Study of the SECOND-LINE Study

Clinical trial2025-06-26Results posted · ClinicalTrials.gov

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME

Clinical trial2025-06-17Results posted · ClinicalTrials.gov

Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA)

Clinical trial2024-01-01Completed · ClinicalTrials.gov

Research In Viral Eradication of HIV Reservoirs

Clinical trial2023-10-23Results posted · ClinicalTrials.gov

Raltegravir 1200 mg Once Daily vs 400 mg Twice Daily, With Emtricitabine and Tenofovir Disoproxil Fumarate, for Previously Untreated HIV-1 Infection: Week 96 Results From ONCEMRK, a Randomized, Double-Blind, Noninferiority Trial.

Research2018-08-01Journal of acquired immune deficiency syndromes (1999)

Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.

Research2017-09-11The lancet. HIV

Reduced platelet hyperreactivity and platelet-monocyte aggregation in HIV-infected individuals receiving a raltegravir-based regimen.

Research2014-09-01AIDS (London, England)

Genetic and non-genetic determinants of raltegravir penetration into cerebrospinal fluid: a single arm pharmacokinetic study.

Research2013-12-11PloS one

Accelerated approval: Isentress (EMA)

Regulatory2007-12-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Raltegravir
Aliases & brands
Isentress
RxNorm CUI
719872
ChEMBL ID
CHEMBL254316
UNII
22VKV8053U
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-12-19
Latest approval
2007-12-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-12-19Accelerated approval
Accelerated approval: Isentress (EMA)

Indication: Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

132 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
132
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
81
Late-stage (III+)
108
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 132
Early Phase 11Phase 130Phase 1 / 23Phase 217Phase 2 / 33Phase 319Phase 439Phase N / A20

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

CompletedPH IVUniversity of Hawaiin=802021

Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study

Unknown statusPH IVFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Saludn=502021

Effect on Liver Fat, Adipose Tissue and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Once Daily Raltegravir in HIV+ Patients With Body Mass Index Over 25 kg/m2 and With at Least One Metabolic Syndrome Component

CompletedPH IVHelsinki University Central Hospitaln=452019

Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)

CompletedPH IVAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infectionsn=5452018

A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission: NICHD P1081

CompletedPH IVWestatn=4082018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA)

CompletedPH IIUniversity of Albertan=372024

Research In Viral Eradication of HIV Reservoirs

CompletedPH IIImperial College Londonn=602023

Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Clinical Trial (NCT02284035)

CompletedPH IIIJudit Pichn=332022

Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

CompletedPH IVUniversity of Hawaiin=802021

A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults

CompletedPH IIIViiV Healthcaren=7242021

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME

CompletedPH IIIFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencian=612020

Research activity

14 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092018
Most influential

Effect of raltegravir-containing intensification on HIV burden and T-cell activation in multiple gut sites of HIV-positive adults on suppressive antiretroviral therapy.

AIDS (London, England) · 2010 · 196 cites

A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response.

The Journal of infectious diseases · 2011 · 162 cites

Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study.

The Lancet. Infectious diseases · 2012 · 130 cites

Raltegravir treatment intensification does not alter cerebrospinal fluid HIV-1 infection or immunoactivation in subjects on suppressive therapy.

The Journal of infectious diseases · 2011 · 58 cites

Intensification of antiretroviral therapy with raltegravir or addition of hyperimmune bovine colostrum in HIV-infected patients with suboptimal CD4+ T-cell response: a randomized controlled trial.

The Journal of infectious diseases · 2011 · 47 cites

Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers.

Antimicrobial agents and chemotherapy · 2010 · 45 cites
Recent papers

Raltegravir 1200 mg Once Daily vs 400 mg Twice Daily, With Emtricitabine and Tenofovir Disoproxil Fumarate, for Previously Untreated HIV-1 Infection: Week 96 Results From ONCEMRK, a Randomized, Double-Blind, Noninferiority Trial.

Journal of acquired immune deficiency syndromes (1999) · 2018 · 16 cites

Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.

The lancet. HIV · 2017 · 21 cites

Reduced platelet hyperreactivity and platelet-monocyte aggregation in HIV-infected individuals receiving a raltegravir-based regimen.

AIDS (London, England) · 2014 · 31 cites

Bone mineral density in HIV participants randomized to raltegravir and lopinavir/ritonavir compared with standard second line therapy.

AIDS (London, England) · 2013 · 27 cites

HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy.

PloS one · 2013 · 13 cites

Genetic and non-genetic determinants of raltegravir penetration into cerebrospinal fluid: a single arm pharmacokinetic study.

PloS one · 2013 · 9 cites
Major research themes4
HIV-12Colostrum1Genetic Association Studies1HIV Seronegativity1
Journals, researchers & institutions
Top journals
  • AIDS (London, England)3
  • The Journal of infectious diseases3
  • PloS one2
  • AIDS patient care and STDs1
  • Antimicrobial agents and chemotherapy1
  • Journal of acquired immune deficiency syndromes (1999)1
Leading researchers
  • Boyd MA3
  • Cooper DA3
  • Emery S3
  • Molina JM3
  • Palmer S3
  • Sinclair E3
  • Bloch M2
  • Cahn P2
Leading institutions
free-text, unnormalised
  • Faculty of Medicine Siriraj Hospital2
  • Thomas Jefferson University2
  • University of California2
  • University of Witwatersrand2
  • aThe Kirby Institute1
  • Brigham & Women's Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.