Summary
Rifabutin 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 ClinicalTrials.gov lists 8 registered trials linking Rifabutin to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00023400). The largest enrolment is 750 participants (NCT00002267). Registration activity spans 2000 to 2013. The literature layer holds 14 publications for this pair: 4 Cochrane reviews, 2 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2007 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 | 75.0 (trials 25.0, 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 | 14 (5 clinical trial publications, 4 Cochrane reviews, 2 meta-analyses, 2 randomised controlled trial publications, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00023400 | TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB 2000 | completed | Phase 4 | 20 |
| NCT00001047 | Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS | completed | Phase 3 | 400 |
| NCT00001058 | A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS | completed | Phase 2 | 246 |
| NCT01894776 | A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc 2013 | completed | Phase 1 | 15 |
| NCT00646776 | Drug Interaction Study 2008 | completed | Phase 1 | 85 |
| NCT00000877 | Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults | completed | Phase 1 | 31 |
| NCT00002267 | Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial | completed | Not applicable | 750 |
| NCT00018083 | Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen | status unknown | Not applicable | — |
Published literature
- Meta-analysis Comparing clinical outcomes of antibiotics for treating Mycobacterium avium complex infection in adults with HIV: a systematic review and network meta-analysisAsuphon O, Boonpattharatthiti K, Rattanachaisit N et al. · AIDS (London, England) · 2026 · PMID 40948420
- Clinical trial publication Safety and Pharmacokinetics of Double-Dose Lopinavir/Ritonavir + Rifampin Versus Lopinavir/Ritonavir + Daily Rifabutin for Treatment of Human Immunodeficiency Virus-Tuberculosis CoinfectionKendall MA, Lalloo U, Fletcher CV et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021 · PMID 34398956
- Systematic review Influence of Malnutrition on the Pharmacokinetics of Drugs Used in the Treatment of Poverty-Related Diseases: A Systematic ReviewVerrest L, Wilthagen EA, Beijnen JH et al. · Clinical pharmacokinetics · 2021 · PMID 34060020
- Clinical trial publication Effect of SLCO1B1 Polymorphisms on Rifabutin Pharmacokinetics in African HIV-Infected Patients with TuberculosisHennig S, Naiker S, Reddy T et al. · Antimicrobial agents and chemotherapy · 2016 · PMID 26482301
- Clinical trial publication Pharmacokinetics and safety of rifabutin in young HIV-infected children receiving rifabutin and lopinavir/ritonavirMoultrie H, McIlleron H, Sawry S et al. · The Journal of antimicrobial chemotherapy · 2015 · PMID 25281400
- Clinical trial publication Randomized pharmacokinetic evaluation of different rifabutin doses in African HIV- infected tuberculosis patients on lopinavir/ritonavir-based antiretroviral therapyNaiker S, Connolly C, Wiesner L et al. · BMC pharmacology & toxicology · 2014 · PMID 25406657
- Clinical trial publication Randomised pharmacokinetic trial of rifabutin with lopinavir/ritonavir-antiretroviral therapy in patients with HIV-associated tuberculosis in VietnamLan NT, Thu NT, Barrail-Tran A et al. · PloS one · 2014 · PMID 24465443
- Cochrane review Interventions for the prevention of mycobacterium avium complex in adults and children with HIVUthman MM, Uthman OA, Yahaya I · The Cochrane database of systematic reviews · 2013 · PMID 23633339
- Randomized controlled trial Effect of rifampin and rifabutin on the pharmacokinetics of lersivirine and effect of lersivirine on the pharmacokinetics of rifabutin and 25-O-desacetyl-rifabutin in healthy subjectsVourvahis M, Davis J, Wang R et al. · Antimicrobial agents and chemotherapy · 2012 · PMID 22644026
- Randomized controlled trial Determination of rifabutin dosing regimen when administered in combination with ritonavir-boosted atazanavirZhang J, Zhu L, Stonier M et al. · The Journal of antimicrobial chemotherapy · 2011 · PMID 21712242
- Cochrane review HIV: primary and secondary prophylaxis for opportunistic infectionsAberg J, Powderly W · BMJ clinical evidence · 2010 · PMID 21418688
- Meta-analysis Treatment of active tuberculosis in HIV-coinfected patients: a systematic review and meta-analysisKhan FA, Minion J, Pai M et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2010 · PMID 20353364
- Cochrane review HIV: treating tuberculosisPayne B, Bellamy R · BMJ clinical evidence · 2009 · PMID 21726477
- Cochrane review Tuberculosis in people with HIVPayne B, Bellamy R · BMJ clinical evidence · 2007 · PMID 19454087
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 Rifabutin approved for HIV/AIDS?
Rifabutin 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 Rifabutin in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Rifabutin to HIV/AIDS: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00023400). The largest enrolment is 750 participants (NCT00002267). Registration activity spans 2000 to 2013.
What does the evidence show for Rifabutin in HIV/AIDS?
Rifabutin 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.