Summary
Tenofovir Disoproxil Fumarate 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 Tenofovir Disoproxil Fumarate to HIV/AIDS: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01778413). The largest enrolment is 500 participants (NCT05492565). Registration activity spans 2003 to 2028. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2024 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 | 73.5 (trials 23.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 systematic reviews, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01778413 | Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine 2013 | completed | Phase 4 | 61 |
| NCT01118871 | The First Failure Study 2010 | terminated | Phase 4 | 3 |
| NCT03708861 | Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients 2016 | withdrawn | Phase 3 | — |
| NCT00099632 | Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy 2006 | completed | Phase 2 | 484 |
| NCT04898699 | IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya 2021 | completed | Early Phase 1 | 120 |
| NCT00051831 | Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults 2003 | completed | Not applicable | 19 |
| NCT05492565 | Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis 2020 | enrolling by invitation | Not applicable | 500 |
| NCT06766331 | Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans 2028 | not yet recruiting | Not applicable | 60 |
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 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 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 Lenacapavir as pre-exposure prophylaxis for HIV preventionEbrahim S, Gloeck N, Adam Z et al. · The Cochrane database of systematic reviews · 2026 · PMID 41919720
- Randomized controlled trial Efficacy of dolutegravir plus lamivudine in treatment-naïve people with HIV with baseline transmitted drug-resistance mutationsCordova E, Hernandez Rendon J, Arevalo Calderon G et al. · AIDS (London, England) · 2026 · PMID 41537536
- Cochrane review Population Pharmacokinetic Simulations for Dose Optimization of Tenofovir Disoproxil Fumarate in HIV-Infected Patients with Moderate-to-Severe Renal ImpairmentBoonpeng A, Singkham N, Wutthikul C et al. · Journal of clinical pharmacology · 2025 · PMID 39415758
- Meta-analysis Chronic kidney disease among people living with HIV on TDF based regimen: A systematic review and meta-analysisYazie TS, Shiferaw WS, Gebeyehu AA et al. · PloS one · 2025 · PMID 39913460
- 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 Performance of Adherence Measures for Oral, Tenofovir-Based HIV Pre-Exposure Prophylaxis: A Systematic ReviewZeballos D, Guimarães NS, Pereira M et al. · AIDS and behavior · 2025 · PMID 40327271
- Cochrane review Risk of dyslipidaemia in people living with HIV who are taking tenofovir alafenamide: a systematic review and meta-analysisYoo JJ, Jung EA, Kim SG et al. · Journal of the International AIDS Society · 2024 · PMID 39301685
- Cochrane review Adherence and HIV Protection Thresholds for Emtricitabine and Tenofovir Disoproxil Fumarate Preexposure Prophylaxis among Cisgender Women: A Systematic ReviewWu L, Niu X, Brunelli MK et al. · Current HIV/AIDS reports · 2024 · PMID 39120667
- Cochrane review Low clinical impact of HIV drug resistance mutations in oral pre-exposure prophylaxis: a systematic review and meta-analysisRachman BE, Khairunisa SQ, Wungu CDK et al. · AIDS research and therapy · 2024 · PMID 38844950
- Meta-analysis Neuropsychiatric adverse events in tenofovir disoproxil fumarate- and tenofovir alafenamide-based HIV therapy and prophylaxis: a systematic review and meta‑analysisGräfe M, Schäfer MS, Leithner C et al. · Polish archives of internal medicine · 2024 · PMID 39387623
- Systematic review Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV, Part II: Drugs Licensed Before 2005Toledo T, Oliveira VG, Cattani VB et al. · Clinical pharmacokinetics · 2024 · PMID 39542985
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 Tenofovir Disoproxil Fumarate approved for HIV/AIDS?
Tenofovir Disoproxil Fumarate 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 Tenofovir Disoproxil Fumarate in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Tenofovir Disoproxil Fumarate to HIV/AIDS: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01778413). The largest enrolment is 500 participants (NCT05492565). Registration activity spans 2003 to 2028.
What does the evidence show for Tenofovir Disoproxil Fumarate in HIV/AIDS?
Tenofovir Disoproxil Fumarate 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.