Summary
Lopinavir 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 ClinicalTrials.gov lists 8 registered trials linking Lopinavir to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01533272). The largest enrolment is 484 participants (NCT00099632). Registration activity spans 2006 to 2023. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2017 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 | 79.0 (trials 29.0, 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 | 16 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 1 systematic review, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| 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 |
| NCT01533272 | Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP) 2012 | completed | Phase 4 | 240 |
| NCT02369965 | Test Albuvirtide in Experienced Patients 2014 | completed | Phase 3 | 418 |
| NCT00437476 | Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy 2007 | status unknown | Phase 3 | 60 |
| NCT01296152 | Pharmacokinetic Interactions Between DMPA and LPV/r Among HIV-Infected Women 2011 | completed | Phase 2 | 25 |
| NCT00099632 | Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy 2006 | completed | Phase 2 | 484 |
| NCT05850728 | First in Human Study of TLC-ART 101 (ACTU 2001) 2023 | completed | Phase 1 | 12 |
| NCT00585793 | Relationship Between HIV-1 Subtype and ARV Response 2008 | completed | Not applicable | 108 |
Published literature
- Clinical trial publication Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trialTurkova A, White E, Violari A et al. · The Lancet. Child & adolescent health · 2026 · PMID 41579881
- Clinical trial publication Pharmacokinetics of Dexamethasone in Tuberculous MeningitisCalderin JM, Resendiz-Galvan JE, Abdelgawad N et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026 · PMID 41408415
- Cochrane review Effectiveness and safety of darunavir and lopinavir for treating children and adolescents living with HIV: a systematic reviewO'Rourke J, Townsend CL, Milanzi E et al. · BMC infectious diseases · 2026 · PMID 41933292
- Clinical trial publication ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept studyPersaud D, Coletti A, Nelson BS et al. · The lancet. HIV · 2025 · PMID 41015049
- Clinical trial publication Population pharmacokinetics of ritonavir as a booster of lopinavir, atazanavir, or darunavir in African children with HIVTsirizani L, Waalewijn H, Szubert A et al. · Antimicrobial agents and chemotherapy · 2025 · PMID 41004270
- Clinical trial publication Bictegravir, emtricitabine, and tenofovir alafenamide versus ritonavir-boosted protease inhibitor-based antiretroviral therapy in people with HIV and viral suppression on second-line therapy in Haiti: an open-label, randomised, non-inferiority trialSevere P, Pierre S, Homeus F et al. · The lancet. HIV · 2025 · PMID 40883049
- Cochrane review Efficacy of artemisinin-based combination therapy (ACT) in people living with HIV (PLHIV) diagnosed with uncomplicated Plasmodium falciparum malaria in Africa: a WWARN systematic reviewTakyi A, Soma A, Przybylska M et al. · Malaria journal · 2025 · PMID 40380136
- Meta-analysis Adverse perinatal outcomes associated with different classes of antiretroviral drugs in pregnant women with HIVHey M, Thompson L, Portwood C et al. · AIDS (London, England) · 2025 · PMID 39407417
- Randomized controlled trial Second-Line Antiretroviral Therapy for Children Living with HIV in AfricaMusiime V, Bwakura-Dangarembizi M, Szubert AJ et al. · The New England journal of medicine · 2025 · PMID 40367375
- 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
- Cochrane review Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virusUgwu EO, Eleje GU, Ugwu AO et al. · The Cochrane database of systematic reviews · 2023 · PMID 37306558
- 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
- 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
- Cochrane review Adverse perinatal outcomes associated with antiretroviral therapy regimens: systematic review and network meta-analysisTshivuila-Matala COO, Honeyman S, Nesbitt C et al. · AIDS (London, England) · 2020 · PMID 32701581
- Meta-analysis Atazanavir / ritonavir versus Lopinavir / ritonavir-based combined antiretroviral therapy (cART) for HIV-1 infection: a systematic review and meta-analysisTigabu BM, Agide FD, Mohraz M et al. · African health sciences · 2020 · PMID 33402897
- Cochrane review Comparative efficacy and safety of second-line antiretroviral therapy for treatment of HIV/AIDS: a systematic review and network meta-analysisKanters S, Socias ME, Paton NI et al. · The lancet. HIV · 2017 · PMID 28784426
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 Lopinavir approved for HIV/AIDS?
Lopinavir 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 Lopinavir in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Lopinavir to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01533272). The largest enrolment is 484 participants (NCT00099632). Registration activity spans 2006 to 2023.
What does the evidence show for Lopinavir in HIV/AIDS?
Lopinavir 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.