Summary
Cabotegravir 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trials linking Cabotegravir to HIV/AIDS: 4 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05986084). The largest enrolment is 687 participants (NCT04542070). Registration activity spans 2019 to 2024. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 3 randomised controlled trial publications 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 | 76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 4 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 randomised controlled trial publications, 2 meta-analyses, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05986084 | Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana 2023 | active, not recruiting | Phase 4 | 500 |
| NCT03635788 | The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE 2019 | active, not recruiting | Phase 3 | 456 |
| NCT04542070 | A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed 2020 | completed | Phase 3 | 687 |
| NCT04484337 | Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants 2020 | completed | Phase 1 | 138 |
| NCT06145854 | Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP 2024 | active, not recruiting | Not applicable | 100 |
| NCT05152953 | Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART) 2022 | completed | Not applicable | 63 |
| NCT06565013 | Chemsex Health Evaluation With Extended Release System for HIV Treatment 2024 | not yet recruiting | Not applicable | 50 |
| NCT05949203 | Oregon PrEP at Home Study 2023 | status unknown | Not applicable | 125 |
Published literature
- Clinical trial publication Feasibility, Fidelity, and Effectiveness of Administering Long-Acting Cabotegravir + Rilpivirine in Infusion Centers in the United States: Findings From the Phase 4 GLACIER Implementation StudyGutner CA, Harrington C, Bontempo G et al. · Journal of the International Association of Providers of AIDS Care · 2026 · PMID 42117620
- Clinical trial publication Advancing youth HIV prevention and care in Uganda: stakeholder-informed innovations through implementation science, protocol for a randomized controlled trialKabugho E, King RL, Mirembe BG et al. · BMC health services research · 2026 · PMID 41639731
- Clinical trial publication Long-acting HIV pre-exposure prophylaxis integrated with community-based sexual and reproductive health services in South Africa (LAPIS): study protocol for a hybrid (1a) cluster randomised controlled phase 3B trial of effectiveness and implementationBusang J, Zuma T, Chimbindi N et al. · BMC public health · 2026 · PMID 41559582
- Clinical trial publication Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm studyGaur AH, Baltrusaitis K, Capparelli EV et al. · The lancet. HIV · 2026 · PMID 41547359
- Clinical trial publication Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trialLowenthal ED, Chapman J, Baltrusaitis K et al. · The lancet. HIV · 2026 · PMID 41547358
- 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
- Cochrane review Outcomes of real-world initiation of long-acting injectable cabotegravir and rilpivirine (LA-I CAB + RPV) in individuals with viraemia: A systematic review of baseline characteristics, virological failure outcomes and discontinuationsElias A, Pasin C, Smuk M et al. · HIV medicine · 2026 · PMID 40944511
- Meta-analysis Rapid diagnostic tests, laboratory-based immunoassay and nucleic acid testing strategies for long-acting injectable pre-exposure prophylaxis: A systematic review and meta-analysisTieosapjaroen W, Williams E, Johnson CC et al. · PLoS medicine · 2026 · PMID 41990088
- Randomized controlled trial Cabotegravir and rilpivirine for treatment of HIV infection in Africa: week 96 results from the phase 3b randomized, open-label, noninferiority CARES trialKityo C, Mambule IK, Musaazi J et al. · Nature medicine · 2026 · PMID 41188524
- Cochrane review The safety of cabotegravir in pregnancy: a systematic review and meta-analysisJasper A, Fourie W, Chetty S · BMC infectious diseases · 2025 · PMID 41225339
- Cochrane review Long-acting injectable cabotegravir and rilpivirine in observational cohort studies: A systematic review on virological failure, resistance and re-suppression outcomes in virally suppressed individuals living with HIVRing K, Elias A, Devonald M et al. · HIV medicine · 2025 · PMID 40511953
- 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 Cabotegravir Plus Rilpivirine Injection for Virally Suppressed Persons with HIV-1 infection: A Systematic Review and Meta-Analysis of Randomized Controlled TrialsHedima EW, Ohieku JD, Nasir A et al. · Clinical therapeutics · 2025 · PMID 40517074
- Randomized controlled trial Evaluation of pharmacokinetic interactions between long-acting cabotegravir or emtricitabine/tenofovir disoproxil fumarate and hormonal contraceptive agents: a tertiary analysis of South African participants in HPTN 084Marzinke MA, Hanscom B, Haines D et al. · Journal of the International AIDS Society · 2025 · PMID 41169120
- Randomized controlled trial Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR studyAdachi E, Yokomaku Y, Watanabe D et al. · Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2025 · PMID 41110828
- Systematic review High Virologic Suppression and Favorable Profiles of Two-Drug Antiretroviral Regimens in Africa: A Systematic Review of Current EvidenceAkpa PA, Isah A, Cocohoba J et al. · Clinical pharmacology and therapeutics · 2025 · PMID 41146527
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 Cabotegravir approved for HIV/AIDS?
Cabotegravir 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 Cabotegravir in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Cabotegravir to HIV/AIDS: 4 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05986084). The largest enrolment is 687 participants (NCT04542070). Registration activity spans 2019 to 2024.
What does the evidence show for Cabotegravir in HIV/AIDS?
Cabotegravir 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.