Summary
Abacavir Sulfate 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ClinicalTrials.gov lists 8 registered trials linking Abacavir Sulfate to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00978237). The largest enrolment is 300 participants (NCT00001086). Registration activity spans 2004 to 2020. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2009 to 2024. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 47.5 (trials 23.5, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 2 (2 clinical 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| 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 |
| NCT00427297 | Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya 2007 | terminated | Phase 3 | 34 |
| NCT04155554 | Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen 2020 | status unknown | Phase 3 | 100 |
| NCT00001086 | A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients | completed | Phase 2 | 300 |
| NCT00087945 | Blood Levels of Abacavir in HIV Infected Adolescents 2004 | completed | Not applicable | 30 |
| NCT00433992 | Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications 2006 | completed | Not applicable | 56 |
| NCT03760458 | The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age 2020 | completed | PHASE1, PHASE2 | 57 |
| NCT02708342 | Observational, Retrospective Analysis in HIV-1 Infected Patients. (ORASWIRAL) 2016 | completed | Not applicable | 100 |
Published literature
- Clinical trial publication Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trialsOrkin C, Molina JM, Cahn P et al. · The lancet. HIV · 2024 · PMID 38141637
- Clinical trial publication Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatmentSmith KY, Patel P, Fine D et al. · AIDS (London, England) · 2009 · PMID 19542866
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 Abacavir Sulfate approved for HIV/AIDS?
Abacavir Sulfate 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 Abacavir Sulfate in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Abacavir Sulfate to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00978237). The largest enrolment is 300 participants (NCT00001086). Registration activity spans 2004 to 2020.
What does the evidence show for Abacavir Sulfate in HIV/AIDS?
Abacavir Sulfate has 6 completed trials and 2 linked publications for HIV/AIDS. Completed trials may or may not have posted results; follow the NCT links to check. 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.