Summary
Amprenavir 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 ClinicalTrials.gov lists 8 registered trials linking Amprenavir to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00192660). The largest enrolment is 328 participants (NCT00056641). Registration activity spans 1998 to 2009. The literature layer holds 11 publications for this pair: 1 meta-analysis, 5 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2008 to 2023. 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 | 75.0 (trials 26.0, literature 29.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 11 (5 clinical trial publications, 5 randomised controlled trial publications, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00148785 | A Pharmacokinetic (PK) Study of a Combination of Indinavir, Ritonavir, and Amprenavir 2005 | completed | Phase 4 | 15 |
| NCT00192660 | HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) 2003 | completed | Phase 4 | 80 |
| NCT00089583 | 48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection 2004 | completed | Phase 2 | 110 |
| NCT00056641 | Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients 2003 | completed | Phase 2 | 328 |
| NCT00071760 | Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects 2003 | completed | Phase 2 | 59 |
| NCT00001766 | Drug Interactions Among Anti-HIV Agents 1998 | completed | Phase 1 | 22 |
| NCT01054638 | HIV Treatment and CVD Events 2009 | completed | Not applicable | — |
| NCT00006591 | Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment | status unknown | Not applicable | — |
Published literature
- 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
- Clinical trial publication Fosamprenavir with Ritonavir Pharmacokinetics during PregnancyEke AC, Wang J, Amin K et al. · Antimicrobial agents and chemotherapy · 2020 · PMID 32015036
- Clinical trial publication Population pharmacokinetic modeling and simulation of amprenavir following fosamprenavir/ritonavir administration for dose optimization in HIV infected pediatric patientsBarbour AM, Gibiansky L, Wire MB · Journal of clinical pharmacology · 2014 · PMID 25272370
- Clinical trial publication Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old childrenFortuny C, Duiculescu D, Cheng K et al. · The Pediatric infectious disease journal · 2014 · PMID 23811744
- Clinical trial publication Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-infected children aged 4 weeks to 2 years-48-week study dataCotton M, Cassim H, Pavía-Ruz N et al. · The Pediatric infectious disease journal · 2014 · PMID 23811743
- Clinical trial publication Long-term safety study of fosamprenavir-containing regimens in HIV-1-infected patientsWood R, Gathe JC, Givens N et al. · HIV clinical trials · 2013 · PMID 24144895
- Randomized controlled trial Discordant associations between SLCO1B1 521T→C and plasma levels of ritonavir-boosted protease inhibitors in AIDS clinical trials group study A5146Zhang X, Tierney C, Albrecht M et al. · Therapeutic drug monitoring · 2013 · PMID 23503447
- Randomized controlled trial Steady-state amprenavir and tenofovir pharmacokinetics after coadministration of unboosted or ritonavir-boosted fosamprenavir with tenofovir disoproxil fumarate in healthy volunteersLuber AD, Condoluci DV, Slowinski PD et al. · HIV medicine · 2010 · PMID 19863619
- Randomized controlled trial Fosamprenavir/ritonavir in advanced HIV disease (TRIAD): a randomized study of high-dose, dual-boosted or standard dose fosamprenavir/ritonavir in HIV-1-infected patients with antiretroviral resistanceMolina JM, Ait-Khaled M, Rinaldi R et al. · The Journal of antimicrobial chemotherapy · 2009 · PMID 19515730
- Randomized controlled trial Effect of baseline viral susceptibility on response to darunavir/ritonavir versus control protease inhibitors in treatment-experienced HIV type 1-infected patients: POWER 1 and 2Pozniak A, Opravil M, Beatty G et al. · AIDS research and human retroviruses · 2008 · PMID 18844462
- Randomized controlled trial Predictive values of the human immunodeficiency virus phenotype and genotype and of amprenavir and lopinavir inhibitory quotients in heavily pretreated patients on a ritonavir-boosted dual-protease-inhibitor regimenBarrail-Tran A, Morand-Joubert L, Poizat G et al. · Antimicrobial agents and chemotherapy · 2008 · PMID 18285478
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 Amprenavir approved for HIV/AIDS?
Amprenavir 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 Amprenavir in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Amprenavir to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00192660). The largest enrolment is 328 participants (NCT00056641). Registration activity spans 1998 to 2009.
What does the evidence show for Amprenavir in HIV/AIDS?
Amprenavir 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.