Summary
Lamivudine 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trials linking Lamivudine to HIV/AIDS: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00978237). The largest enrolment is 379 participants (NCT01511237). Registration activity spans 1999 to 2024. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2023 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 | 76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00978237 | Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients 2009 | completed | Phase 4 | 20 |
| NCT05979311 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy 2024 | active, not recruiting | Phase 3 | 307 |
| NCT01511237 | Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers 2011 | completed | Phase 3 | 379 |
| NCT03311945 | 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 2018 | completed | Phase 3 | 33 |
| NCT00004998 | Safety and Effectiveness of a New Anti-HIV Drug (AG1549) in Combination With Other Anti-HIV Drugs in HIV-Infected Patients 1999 | suspended | Phase 2 | 30 |
| NCT00000887 | A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants | completed | Phase 1 | 24 |
| NCT00087945 | Blood Levels of Abacavir in HIV Infected Adolescents 2004 | completed | Not applicable | 30 |
| NCT00000875 | Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection | terminated | Not applicable | 16 |
Published literature
- Clinical trial publication Exposure-response modeling of QTc interval and creatine kinase-MB in healthy people and treatment-naïve adults living with HIV-1 treated with ainuovirine monotherapy or combined with lamivudine and tenofovir DFZhou Z, Zhang Y, Yun X et al. · European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2026 · PMID 42086178
- Clinical trial publication Efficacy and safety of short-cycle, dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a multicentre, open-label, randomised, parallel, two-arm, non-inferiority trialKekitiinwa AR, Jennings A, Bwakura-Dangarembizi M et al. · The lancet. HIV · 2026 · PMID 41962560
- 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 Dolutegravir restores gut microbiota in late-stage HIV-1 unlike darunavir: an open-label, randomized clinical trialCatalà-Moll F, Blázquez-Bondia C, Farré-Badia J et al. · Nature communications · 2026 · PMID 41781390
- Clinical trial publication Cardiometabolic impact of dolutegravir as second-line therapy: secondary analysis of a randomized controlled trialNyein PP, Donoghoe MW, Eriobu N et al. · AIDS (London, England) · 2026 · PMID 41779383
- Cochrane review Virological outcomes of dolutegravir-based versus other antiretroviral regimens in people living with HIV: A systematic review and meta-analysisWeldemhret L, Dejene TA, Gebrehiwot GT et al. · BMC infectious diseases · 2026 · PMID 41857703
- Randomized controlled trial Doubling dolutegravir dosage reduces the viral reservoir in ART-treated people with HIVFombellida-Lopez C, Valaitienė A, Winchester L et al. · eLife · 2026 · PMID 41575190
- Cochrane review Comparison of treatment-emergent resistance-associated mutations and discontinuation due to adverse events among integrase strand transfer inhibitor-based single-tablet regimens and cabotegravir + rilpivirine for the treatment of virologically suppressed people with HIV: A systematic literature review and network meta-analysisRashid I, Unger NR, Willis C et al. · HIV medicine · 2025 · PMID 40426337
- Meta-analysis Association of nucleoside reverse transcriptase inhibitors with adverse perinatal outcomes in pregnant women living with HIV: systematic review and meta-analysisCowdell I, Beck K, Hey M et al. · Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2025 · PMID 39848582
- Systematic review Dolutegravir + lamivudine effectiveness and tolerability in real-world cohorts with HIV-1 across Asia and South America: A systematic literature reviewDoblado-Maldonado A, Ooi AYR, Cheng CY et al. · Medicine · 2025 · PMID 40826695
- Cochrane review A Systematical Review on ART Use in HTLV Infection: Clinical, Virological, and Immunological OutcomesFernandez T, Marconi C, Montaño-Castellón I et al. · Pathogens (Basel, Switzerland) · 2024 · PMID 39338913
- Cochrane review Comparison of safety and effectiveness of antiretroviral therapy regimens among pregnant women living with HIV at preconception or during pregnancy: a systematic review and network meta-analysis of randomized trialsMehrabi F, Karamouzian M, Farhoudi B et al. · BMC infectious diseases · 2024 · PMID 38641597
- 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 Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virusUgwu EO, Eleje GU, Ugwu AO et al. · The Cochrane database of systematic reviews · 2023 · PMID 37306558
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 Lamivudine approved for HIV/AIDS?
Lamivudine 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 Lamivudine in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Lamivudine to HIV/AIDS: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00978237). The largest enrolment is 379 participants (NCT01511237). Registration activity spans 1999 to 2024.
What does the evidence show for Lamivudine in HIV/AIDS?
Lamivudine 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.