Summary
Tipranavir 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 ClinicalTrials.gov lists 8 registered trials linking Tipranavir to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00192660). The largest enrolment is 328 participants (NCT00056641). Registration activity spans 1999 to 2014. The literature layer holds 11 publications for this pair: 1 Cochrane review, 2 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2006 to 2024. 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 | 77.0 (trials 27.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 11 (5 clinical trial publications, 2 meta-analyses, 2 systematic reviews, 1 Cochrane 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00966329 | Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects 2009 | completed | Phase 4 | 30 |
| NCT00925756 | CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery 2008 | completed | Phase 4 | 32 |
| NCT00192660 | HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) 2003 | completed | Phase 4 | 80 |
| NCT02302547 | Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy 2014 | completed | Phase 3 | 224 |
| NCT02249130 | Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir 1999 | completed | Phase 2 | 18 |
| NCT00056641 | Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients 2003 | completed | Phase 2 | 328 |
| NCT02239835 | Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients 1999 | terminated | Phase 2 | 79 |
| NCT02229760 | Effect of Steady State TPV/r on Intracellular Concentrations of Zidovudine and Carbovir for Patients With HIV 2006 | terminated | PHASE1, PHASE2 | 3 |
Published literature
- 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
- 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
- Clinical trial publication Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trialde Castro N, Braun J, Charreau I et al. · AIDS research and therapy · 2016 · PMID 27042193
- Clinical trial publication Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter TrialCooper DA, Cordery DV, Zajdenverg R et al. · PloS one · 2016 · PMID 26730818
- Clinical trial publication Regimen selection in the OPTIONS trial of HIV salvage therapy: drug resistance, prior therapy, and race-ethnicity determine the degree of regimen complexityTashima KT, Mollan KR, Na L et al. · HIV clinical trials · 2015 · PMID 26212575
- Clinical trial publication Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experienceSalazar JC, Cahn P, Della Negra M et al. · The Pediatric infectious disease journal · 2014 · PMID 23995585
- Cochrane review Virologic response to tipranavir-ritonavir or darunavir-ritonavir based regimens in antiretroviral therapy experienced HIV-1 patients: a meta-analysis and meta-regression of randomized controlled clinical trialsBerhan A, Berhan Y · PloS one · 2013 · PMID 23593314
- Meta-analysis Efficacy of new antiretroviral drugs in treatment-experienced HIV-infected patients: a systematic review and meta-analysis of recent randomized controlled trialsPichenot M, Deuffic-Burban S, Cuzin L et al. · HIV medicine · 2012 · PMID 22107456
- Clinical trial publication Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trialElgadi MM, Piliero PJ · Drugs in R&D · 2011 · PMID 22007990
- Randomized controlled trial Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trialGallien S, Braun J, Delaugerre C et al. · The Journal of antimicrobial chemotherapy · 2011 · PMID 21712241
- Meta-analysis Concomitant use of an active boosted protease inhibitor with enfuvirtide in treatment-experienced, HIV-infected individuals: recent data and consensus recommendationsYoule M, Staszweski S, Clotet B et al. · HIV clinical trials · 2006 · PMID 16798623
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 Tipranavir approved for HIV/AIDS?
Tipranavir 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 Tipranavir in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Tipranavir to HIV/AIDS: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00192660). The largest enrolment is 328 participants (NCT00056641). Registration activity spans 1999 to 2014.
What does the evidence show for Tipranavir in HIV/AIDS?
Tipranavir 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.