Summary
Elvitegravir 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 ClinicalTrials.gov lists 8 registered trials linking Elvitegravir to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02198443). The largest enrolment is 278 participants (NCT00298350). Registration activity spans 2006 to 2017. The literature layer holds 17 publications for this pair: 3 Cochrane reviews, 3 meta-analyses, 3 systematic reviews, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2016 to 2025. 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 | 78.5 (trials 28.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 17 (5 clinical trial publications, 3 Cochrane reviews, 3 meta-analyses, 3 systematic reviews, 3 randomised controlled 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02351908 | Renal Integrase Study 2015 | completed | Phase 4 | 60 |
| NCT02198443 | Comparison of Two Combinations in Antiretroviral Post-Exposure Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open. 2015 | completed | Phase 4 | 160 |
| NCT02302547 | Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy 2014 | completed | Phase 3 | 224 |
| NCT01694420 | Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet 2012 | completed | Phase 3 | 33 |
| NCT00298350 | Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART. 2006 | completed | Phase 2 | 278 |
| NCT00869557 | Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults 2009 | completed | Phase 2 | 71 |
| NCT03205696 | Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection 2017 | completed | Not applicable | 101 |
| NCT02306577 | STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY) 2014 | status unknown | Not applicable | 30 |
Published literature
- Clinical trial publication Immediate and delayed switches to tenofovir DF-containing, ainuovirine-based antiretroviral regimen: the SPRINT extensional studyZhang F, Cai W, Wu H et al. · BMC medicine · 2025 · PMID 41029679
- Clinical trial publication Pharmacokinetics, safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in children with HIV aged from 2 years and weighing at least 14 kgNatukunda E, Gaur AH, Kosalaraksa P et al. · Journal of the International AIDS Society · 2025 · PMID 39888251
- Clinical trial publication Bictegravir/emtricitabine/tenofovir alafenamide in adults with HIV-1 and end-stage kidney disease on chronic haemodialysisEron JJ, Ramgopal M, Osiyemi O et al. · HIV medicine · 2025 · PMID 39370144
- Cochrane review Deep sequencing reveals underestimated burden of integrase inhibitor resistance mutations in people living with HIV: a global individual patient data meta-analysisYuan D, Zhao F, Liu Y et al. · Emerging microbes & infections · 2025 · PMID 41293884
- Clinical trial publication A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV PreventionRiddler SA, Kelly CW, Hoesley CJ et al. · The Journal of infectious diseases · 2024 · PMID 38655842
- Clinical trial publication A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravirThurman AR, Ouattara LA, Yousefieh N et al. · Frontiers in cellular and infection microbiology · 2023 · PMID 37153145
- Meta-analysis Interactions of Antiretroviral Drugs with Food, Beverages, Dietary Supplements, and Alcohol: A Systematic Review and Meta-analysesWiesner A, Skrońska M, Gawlik G et al. · AIDS and behavior · 2023 · PMID 36318429
- Randomized controlled trial Evaluation of HIV-DNA and residual viremia levels through week 96 in HIV-infected individuals who continue a two-drug or switch to a three-drug integrase strand transfer inhibitor-based regimenScutari R, Galli L, Alteri C et al. · International journal of antimicrobial agents · 2023 · PMID 36870403
- 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
- Cochrane review Effects of different integrase strand transfer inhibitors on body weight in patients with HIV/AIDS: a network meta-analysisBai R, Lv S, Wu H et al. · BMC infectious diseases · 2022 · PMID 35114968
- Randomized controlled trial Immunological and inflammatory changes after simplifying to dual therapy in virologically suppressed HIV-infected patients through week 96 in a randomized trialTrujillo-Rodríguez M, Muñoz-Muela E, Serna-Gallego A et al. · Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022 · PMID 35289296
- Meta-analysis Comparative efficacy, safety and durability of dolutegravir relative to common core agents in treatment-naïve patients infected with HIV-1: an update on a systematic review and network meta-analysisNickel K, Halfpenny NJA, Snedecor SJ et al. · BMC infectious diseases · 2021 · PMID 33637050
- Meta-analysis Network meta-analysis of post-exposure prophylaxis randomized clinical trialsFernández I, de Lazzari E, Inciarte A et al. · HIV medicine · 2021 · PMID 33108035
- Randomized controlled trial A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal function in HIV-1 antiretroviral naïve patientsBracchi M, Pagani N, Dalla Pria A et al. · HIV research & clinical practice · 2021 · PMID 34551678
- Systematic review Therapeutic Drug Monitoring of HIV Antiretroviral Drugs in Pregnancy: A Narrative ReviewO'Kelly B, Murtagh R, Lambert JS · Therapeutic drug monitoring · 2020 · PMID 32004247
- Systematic review Meta-analysis and systematic review of the efficacy and resistance for human immunodeficiency virus type 1 integrase strand transfer inhibitorsYang LL, Li Q, Zhou LB et al. · International journal of antimicrobial agents · 2019 · PMID 31398480
- Cochrane review Therapy-Emergent Drug Resistance to Integrase Strand Transfer Inhibitors in HIV-1 Patients: A Subgroup Meta-Analysis of Clinical TrialsYou J, Wang H, Huang X et al. · PloS one · 2016 · PMID 27532886
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 Elvitegravir approved for HIV/AIDS?
Elvitegravir 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 Elvitegravir in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Elvitegravir to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02198443). The largest enrolment is 278 participants (NCT00298350). Registration activity spans 2006 to 2017.
What does the evidence show for Elvitegravir in HIV/AIDS?
Elvitegravir 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.