Summary
Doravirine 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 Doravirine to HIV/AIDS: 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04233372). The largest enrolment is 641 participants (NCT05766501). Registration activity spans 2012 to 2024. The literature layer holds 10 publications for this pair: 2 Cochrane reviews, 1 meta-analysis, 2 systematic reviews 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 | 79.5 (trials 29.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 10 (5 clinical trial publications, 2 Cochrane reviews, 2 systematic reviews, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04233372 | Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study 2020 | completed | Phase 4 | 399 |
| NCT05648201 | Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers 2023 | completed | Phase 4 | 20 |
| NCT04665375 | Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF? 2021 | terminated | Phase 4 | 4 |
| NCT05766501 | A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) 2023 | active, not recruiting | Phase 3 | 641 |
| NCT01632345 | A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007) 2012 | completed | Phase 2 | 342 |
| NCT06034938 | DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road) 2024 | recruiting | Phase 2 | 32 |
| NCT03894124 | Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers 2019 | completed | Phase 1 | 24 |
| NCT05477407 | Adipose Tissue After Switch to Doravirine 2022 | completed | Not applicable | 22 |
Published literature
- 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 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
- Clinical trial publication Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trialOrkin C, Mngqibisa R, Velez JD et al. · Lancet (London, England) · 2026 · PMID 41654374
- Clinical trial publication Doravirine Resistance Patterns Identified Through Week 192 in the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Clinical TrialsOrkin C, Kuritzkes DR, Katlama C et al. · Journal of acquired immune deficiency syndromes (1999) · 2026 · PMID 41129125
- Clinical trial publication Cardiovascular Risk Assessment Using the Atherosclerotic Cardiovascular Disease Risk Score Model after Continuing or Switching to a Doravirine-Based HIV Treatment RegimenHsue PY, Behrens GMN, Xu ZJ et al. · Journal of acquired immune deficiency syndromes (1999) · 2026 · PMID 41081774
- 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 Efficacy and safety of doravirine/islatravir for the treatment of HIV-1: a systematic review and meta-analysis of randomized controlled trials with GRADE assessmentAbdeldayem MR, Elsherbeeny A, Beddor A · European journal of clinical pharmacology · 2026 · PMID 42343061
- 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
- Meta-analysis Efficacy and safety of doravirine in treatment-naive HIV-1-infected adults: a systematic review and meta-analysisAfify MA, Ahmed IGG, Alkahtani TA et al. · Environmental science and pollution research international · 2021 · PMID 33098001
- Systematic review Clinical Impact of Virological Failure and Resistance Analysis Definitions used in Pivotal Clinical Trials of Initial Antiretroviral Treatment: A Systematic ReviewLlibre JM, Álvarez H, Yzusqui M · AIDS reviews · 2018 · PMID 30264825
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 Doravirine approved for HIV/AIDS?
Doravirine 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 Doravirine in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Doravirine to HIV/AIDS: 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04233372). The largest enrolment is 641 participants (NCT05766501). Registration activity spans 2012 to 2024.
What does the evidence show for Doravirine in HIV/AIDS?
Doravirine 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.