Summary
Etravirine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in HIV/AIDS would be drug repurposing rather than first-in-human development. This does not mean it is approved for HIV/AIDS. ClinicalTrials.gov lists 8 registered trials linking Etravirine to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01422330). The largest enrolment is 224 participants (NCT02302547). Registration activity spans 2007 to 2014. The literature layer holds 16 publications for this pair: 2 Cochrane reviews, 3 meta-analyses, 1 systematic review, 5 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2007 to 2023. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for HIV/AIDS ranks 249 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous elite control (natural viremic suppression without ART) in <1% of people living with HIV; untreated, median time to AIDS ~10 years; viral rebound within weeks of ART interruption in 99%+ of patients.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 79.5 (trials 29.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 16 (5 clinical trial publications, 5 randomised controlled trial publications, 3 meta-analyses, 2 Cochrane reviews, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00925756 | CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery 2008 | completed | Phase 4 | 32 |
| NCT01422330 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Etravirine Administered in Combination With Other Antiretroviral Agents in Antiretroviral Treatment-Experienced HIV-1 Infected Patients 2011 | completed | Phase 4 | 211 |
| NCT01118871 | The First Failure Study 2010 | terminated | Phase 4 | 3 |
| NCT00782301 | Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients 2009 | withdrawn | Phase 4 | — |
| NCT02302547 | Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy 2014 | completed | Phase 3 | 224 |
| NCT01034917 | Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression 2009 | completed | Phase 3 | 43 |
| NCT00903682 | A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients 2009 | completed | Phase 2 | 157 |
| NCT00531323 | TMC 125 Blood Levels Study 2007 | completed | Phase 1 | 24 |
Published literature
- Clinical trial publication Phase I Trial of the Multi-kinase Inhibitor Cabozantinib, a CYP3A4 Substrate, plus CYP3A4-Interacting Antiretroviral Therapy in People Living with HIV and Cancer (AMC-087)Haigentz M Jr, Lee JY, Chiao EY et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · PMID 37523145
- Meta-analysis Interactions of Antiretroviral Drugs with Food, Beverages, Dietary Supplements, and Alcohol: A Systematic Review and Meta-analysesWiesner A, Skrońska M, Gawlik G et al. · AIDS and behavior · 2023 · PMID 36318429
- Systematic review Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic ReviewToledo T, Castro T, Oliveira VG et al. · Clinical pharmacokinetics · 2023 · PMID 37561283
- Clinical trial publication Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimenPalich R, Allavena C, Peytavin G et al. · The Journal of antimicrobial chemotherapy · 2021 · PMID 33099638
- Clinical trial publication Characterization of viral rebounds on dual etravirine/raltegravir maintenance therapy (ANRS-163 ETRAL trial)Soulie C, Assoumou L, Abdi B et al. · The Journal of antimicrobial chemotherapy · 2020 · PMID 32259255
- Clinical trial publication Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy studyGrinsztejn B, Hughes MD, Ritz J et al. · The lancet. HIV · 2019 · PMID 31371262
- Clinical trial publication Lack of a Clinically Significant Pharmacokinetic Interaction between Etravirine and Raltegravir Using an Original Approach Based on Drug Metabolism, Protein Binding, and Penetration in Seminal Fluid: A Pharmacokinetic Substudy of the ANRS-163 ETRAL StudyLê MP, Valantin MA, Assoumou L et al. · Pharmacotherapy · 2019 · PMID 30815916
- Cochrane review Second- and Third-line Antiretroviral Therapy for Children and Adolescents: A Scoping ReviewLazarus E, Nicol S, Frigati L et al. · The Pediatric infectious disease journal · 2017 · PMID 28403052
- Cochrane review Emtricitabine/rilpivirine/tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adultsKabbara WK, Ramadan WH · Journal of infection and public health · 2015 · PMID 26001757
- Randomized controlled trial Archived HIV-1 DNA resistance mutations to rilpivirine and etravirine in successfully treated HIV-1-infected individuals pre-exposed to efavirenz or nevirapineGallien S, Charreau I, Nere ML et al. · The Journal of antimicrobial chemotherapy · 2015 · PMID 25344807
- Randomized controlled trial Efficacy and safety of lersivirine versus etravirine for the treatment of HIV-1 infection in patients with prior non-nucleoside reverse transcriptase inhibitor (NNRTI) use and evidence of NNRTI resistance: a randomized phase 2B trialDeJesus E, Fätkenheuer G, Orrell C et al. · HIV clinical trials · 2014 · PMID 25350959
- Randomized controlled trial Phenotypic and genotypic analyses to guide selection of reverse transcriptase inhibitors in second-line HIV therapy following extended virological failure in UgandaGoodall RL, Dunn DT, Pattery T et al. · The Journal of antimicrobial chemotherapy · 2014 · PMID 24633208
- Randomized controlled trial Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch studyEcheverría P, Bonjoch A, Puig J et al. · PloS one · 2014 · PMID 24503952
- Randomized controlled trial Sensitive testing of plasma HIV-1 RNA and Sanger sequencing of cellular HIV-1 DNA for the detection of drug resistance prior to starting first-line antiretroviral therapy with etravirine or efavirenzGeretti AM, Conibear T, Hill A et al. · The Journal of antimicrobial chemotherapy · 2014 · PMID 24284781
- Meta-analysis Efficacy of new antiretroviral drugs in treatment-experienced HIV-infected patients: a systematic review and meta-analysis of recent randomized controlled trialsPichenot M, Deuffic-Burban S, Cuzin L et al. · HIV medicine · 2012 · PMID 22107456
- Meta-analysis Modelling-based prediction of clinical benefits from etravirine in the TMC125-C223 trialHill A, Grossman H, Cohen C et al. · HIV clinical trials · 2007 · PMID 17507322
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Etravirine approved for HIV/AIDS?
Etravirine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in HIV/AIDS would be drug repurposing rather than first-in-human development. This does not mean it is approved for HIV/AIDS. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Etravirine in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Etravirine to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01422330). The largest enrolment is 224 participants (NCT02302547). Registration activity spans 2007 to 2014.
What does the evidence show for Etravirine in HIV/AIDS?
Etravirine has both completed registered trials and synthesis-level publications linked to HIV/AIDS. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.