Summary
Emtricitabine 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trials linking Emtricitabine to HIV/AIDS: 1 is active or not yet recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01533272). The largest enrolment is 307 participants (NCT05979311). Registration activity spans 2006 to 2024. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2025 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 | 79.0 (trials 29.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 1 meta-analysis, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03502005 | Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 2018 | completed | Phase 4 | 100 |
| 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 |
| NCT01533272 | Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP) 2012 | completed | Phase 4 | 240 |
| NCT01118871 | The First Failure Study 2010 | terminated | Phase 4 | 3 |
| 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 |
| NCT04898699 | IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya 2021 | completed | Early Phase 1 | 120 |
| NCT03512964 | Rapid HIV Treatment Initiation, Access and Engagement in Care 2016 | completed | Not applicable | 32 |
| NCT00433992 | Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications 2006 | completed | Not applicable | 56 |
Published literature
- 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
- Clinical trial publication Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trialRockstroh JK, Kassim S, Paredes R et al. · The lancet. HIV · 2026 · PMID 41763226
- Clinical trial publication Evaluating B/F/TAF at the first HIV-specialist appointment in antiretroviral naive persons living with HIV: the bifast studyAl-Hayani AW, Carrillo-Acosta I, Cabello-Úbeda A et al. · BMC infectious diseases · 2026 · PMID 41703498
- Clinical trial publication Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trialMhlanga FG, Szydlo DW, Mayo AJ et al. · The lancet. HIV · 2026 · PMID 41687672
- Clinical trial publication Short-cycle three-day-per-week efavirenz/emtricitabine/tenofovir disoproxil fumarate therapy: a seven-year extension studyBorjabad B, Rojas J, Inciarte A et al. · The Journal of antimicrobial chemotherapy · 2026 · PMID 41676981
- Cochrane review Efficacy and safety of doravirine/islatravir for HIV-1: a GRADE-assessed systematic review and meta-analysis of randomized controlled trialsM Alghzawi H, Shah SZ, Abideen ZU et al. · HIV research & clinical practice · 2026 · PMID 42400399
- Cochrane review Lenacapavir as pre-exposure prophylaxis for HIV preventionEbrahim S, Gloeck N, Adam Z et al. · The Cochrane database of systematic reviews · 2026 · PMID 41919720
- Meta-analysis Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-experienced people with HIV-1: a systematic literature review and network meta-analysisCurteis T, Eddowes LA, Karlsson A et al. · Journal of comparative effectiveness research · 2026 · PMID 42206806
- Randomized controlled trial Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trialColson AE, Mills AM, Ramgopal MN et al. · Lancet (London, England) · 2026 · PMID 41654375
- Cochrane review Rapid start with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with human immunodeficiency virus-1 (HIV-1): A systematic literature review of clinical and patient-reported outcomesGhosn J, Chow J, Gandhi M et al. · HIV medicine · 2025 · PMID 40566994
- Cochrane review Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-naïve people with HIV-1: a systematic literature review and network meta-analysisCurteis T, Eddowes LA, Chen M et al. · Journal of comparative effectiveness research · 2025 · PMID 40442921
- 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
- Systematic review Oral pre-exposure prophylaxis initiation, continuation and adherence among pregnant and postpartum women receiving antenatal and postnatal care: a systematic reviewRotsaert A, Essack Z, Bosman S et al. · Journal of the International AIDS Society · 2025 · PMID 41059581
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 Emtricitabine approved for HIV/AIDS?
Emtricitabine 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 Emtricitabine in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Emtricitabine to HIV/AIDS: 1 is active or not yet recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01533272). The largest enrolment is 307 participants (NCT05979311). Registration activity spans 2006 to 2024.
What does the evidence show for Emtricitabine in HIV/AIDS?
Emtricitabine 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.