Last reviewed · How we verify
NCT01341184
TMC207 +/- Rifabutin/Rifampin
Completed
Phase 1
Last updated 21 April 2017
What this trial tests
Phase 1 trial testing Rifabutin in Tuberculosis in 33 participants. Completed in 23 May 2012.
Timeline
21 October 2011
Primary endpoint
23 May 2012
23 May 2012
23 May 2012
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 21 October 2011 |
| Primary completion | 23 May 2012 |
| Estimated completion | 23 May 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 45, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy volunteers
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers.
Healan AM, Griffiss JM, Proskin HM, O'Riordan MA, et al · · 2018 · cited 22× · PMID 29061739 · DOI 10.1128/aac.00855-17 -
Recently developed drugs for the treatment of drug-resistant tuberculosis: a research and development case study.
Perrin C, Athersuch K, Elder G, Martin M, et al · · 2022 · cited 15× · PMID 35440441 · DOI 10.1136/bmjgh-2021-007490 -
TB and HIV Therapeutics: Pharmacology Research Priorities.
Dooley KE, Kim PS, Williams SD, Hafner R. · · 2012 · cited 14× · PMID 22829999 · DOI 10.1155/2012/874083 -
Advances of new drugs bedaquiline and delamanid in the treatment of multi-drug resistant tuberculosis in children.
Zhu H, Zhou X, Zhuang Z, Li L, et al · · 2023 · cited 11× · PMID 37384221 · DOI 10.3389/fcimb.2023.1183597 -
Mycobactericidal activity of bedaquiline plus rifabutin or rifampin in ex vivo whole blood cultures of healthy volunteers: A randomized controlled trial.
Wallis RS, Good CE, O'Riordan MA, Blumer JL, et al · · 2018 · cited 7× · PMID 29718967 · DOI 10.1371/journal.pone.0196756
Verify or expand the search:
- PubMed search for NCT01341184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rifabutin
Trials testing the same drug.
- NCT07514364 — The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance · Phase 4 · recruiting
- NCT07199452 — A Study of Rifabutin and MK-4646 in Healthy Participants (MK-4646-004) · Phase 1 · completed
- NCT07066722 — A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults · Phase 1 · completed
- NCT06731023 — Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extreme · not yet recruiting
- NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2, PHASE3 · active not recruiting
Other recruiting trials for Tuberculosis
Currently open trials in the same condition.
- NCT05917210 — Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda · NA · recruiting
- NCT07170735 — Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level · recruiting
- NCT07484490 — Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis · NA · recruiting
- NCT06318416 — Precision Rifampin Trial for Personalized Dosing · Phase 1 · recruiting
- NCT07170800 — A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets · Phase 2 · recruiting
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
- NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
- NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
- NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
- NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
- NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01341184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 21 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01341184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing