Summary
Nevirapine 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 ClinicalTrials.gov lists 8 registered trials linking Nevirapine to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00986063). The largest enrolment is 2009 participants (NCT00001135). Registration activity spans 2004 to 2016. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 5 meta-analyses, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2018 to 2026. 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 | 80.0 (trials 30.0, 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 | 17 (5 Cochrane reviews, 5 meta-analyses, 5 clinical trial publications, 2 randomised controlled trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00703898 | Durability of Nevirapine-Based Antiretroviral Regimen 2004 | completed | Phase 4 | 140 |
| NCT00986063 | Genotype Based Personalized Prescription of Nevirapine 2009 | completed | Phase 4 | 1,200 |
| NCT03088410 | Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana 2016 | completed | Phase 4 | 495 |
| NCT01728961 | Pharmacology of Antimalarial Therapy With or Without Antiretroviral Therapy 2012 | terminated | Phase 4 | 19 |
| NCT01511237 | Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers 2011 | completed | Phase 3 | 379 |
| NCT00001135 | A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants | completed | Phase 3 | 2,009 |
| NCT00427297 | Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya 2007 | terminated | Phase 3 | 34 |
| NCT00099632 | Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy 2006 | completed | Phase 2 | 484 |
Published literature
- Clinical trial publication Comparative evaluation of human T lymphocytes in HIV patients treated with lamivudine + zidovudine combined with nevirapine versus efavirenzZhu X, Zou M · Medicine · 2026 · PMID 41961664
- Clinical trial publication Regional Variations of Rates and Determinants of Drug Resistance Mutations in People Failing First-line Therapy for HIV-1: A Substudy from the D2EFT Phase 3b/4 Clinical TrialObeng BM, Hutchinson J, Shaik A et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026 · PMID 41482685
- Clinical trial publication Brief Report: Postpartum Maternal Monitoring for Renal Safety Related to Tenofovir Exposure During Breastfeeding in the PROMISE 1077BF Randomized TrialBaltrusaitis K, Tierney C, Fowler MG et al. · Journal of acquired immune deficiency syndromes (1999) · 2026 · PMID 41474755
- Clinical trial publication Maternal and health worker preferences for paediatric antiretroviral formulations in neonates exposed to HIVPurdy C, Luke V, du Toit S et al. · AIDS care · 2026 · PMID 41348547
- Cochrane review Insights from systematic reviews (2019-2024) and drug interaction database analysis in people with HIV and comorbiditiesBoonyong C, Boonsing P, Ruangritpassorn L et al. · International journal of STD & AIDS · 2026 · PMID 41171993
- Randomized controlled trial Hepatotoxicity Among People With HIV and Receiving Isoniazid Preventive Therapy in Pregnancy and Postpartum: The Role of Antiretroviral Regimen and PharmacogeneticsMontepiedra G, Aaron L, Theron G et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026 · PMID 40237651
- Clinical trial publication ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept studyPersaud D, Coletti A, Nelson BS et al. · The lancet. HIV · 2025 · PMID 41015049
- Cochrane review Efficacy of artemisinin-based combination therapy (ACT) in people living with HIV (PLHIV) diagnosed with uncomplicated Plasmodium falciparum malaria in Africa: a WWARN systematic reviewTakyi A, Soma A, Przybylska M et al. · Malaria journal · 2025 · PMID 40380136
- Meta-analysis Epidemiology of Antiretroviral Therapy Related Adverse Drug Reactions and its Predictors Among Patients with Human Immunodeficiency Virus/AIDS in Ethiopia: A Systematic Review and Meta-analysisZewdu WS, Dagnew SB, Zeleke MM et al. · Journal of the International Association of Providers of AIDS Care · 2025 · PMID 40665675
- Meta-analysis Magnitude and characteristics of unsuppressed HIV viral load in children and adolescents on antiretroviral therapy in sub-Saharan Africa: a systematic review and meta-analysisMukuku O, Govender K, Wembonyama SO et al. · The lancet. HIV · 2025 · PMID 40473447
- Meta-analysis Prevalence and predictors of virological failure among the people living with HIV on antiretroviral treatment in East Africa: evidence from a systematic review with meta-analysis and meta-regression of published studies from 2016 to 2023Namaganda MM, Mukasa Kafeero H, Nakatumba Nabende J et al. · HIV research & clinical practice · 2025 · PMID 40219653
- Randomized controlled trial Bone mineral density changes in breastfeeding women with HIV on antiretroviral therapy in Eastern and Southern AfricaMatovu Kiweewa F, Stranix-Chibanda L, Yende-Zuma N et al. · AIDS (London, England) · 2025 · PMID 39918445
- Meta-analysis Burden of virologic failure, and its determinants among HIV positive children in East Africa: a systematic review and meta-analysisTemere BC, Mewahegn AA, Zewudie BT et al. · African health sciences · 2024 · PMID 40777957
- Meta-analysis Risk of viral failure after simplification therapy without using integrase inhibitors compared with maintenance of triple antiretroviral therapy: A systematic review and meta-analysisHelfer MS, Sprinz E · The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases · 2024 · PMID 39556960
- Cochrane review Associations between human leukocyte antigen polymorphisms and hypersensitivity to antiretroviral therapy in patients with human immunodeficiency virus: a meta-analysisHu K, Xiang Q, Wang Z et al. · BMC infectious diseases · 2019 · PMID 31277607
- Cochrane review Comparative safety and effectiveness of perinatal antiretroviral therapies for HIV-infected women and their children: Systematic review and network meta-analysis including different study designsVeroniki AA, Antony J, Straus SE et al. · PloS one · 2018 · PMID 29912896
- Cochrane review Optimal Antiretroviral Prophylaxis in Infants at High Risk of Acquiring HIV: A Systematic ReviewBeste S, Essajee S, Siberry G et al. · The Pediatric infectious disease journal · 2018 · PMID 29319636
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 Nevirapine approved for HIV/AIDS?
Nevirapine 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 Nevirapine in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Nevirapine to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00986063). The largest enrolment is 2009 participants (NCT00001135). Registration activity spans 2004 to 2016.
What does the evidence show for Nevirapine in HIV/AIDS?
Nevirapine 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.