Pulmonary TuberculosisPhase 2NCT00694629
TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
A Phase 2 study testing rifapentine, rifapentine 10 mg/kg and rifapentine 15 mg/kg in people with Pulmonary Tuberculosis, run by Centers for Disease Control and Prevention at 29 sites in 6 countries.
Trial summary
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- rifapentine, rifapentine 10 mg/kg and rifapentine 15 mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Dec 2008to Dec 2013
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment.
- 5 (five) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding initiation of study drugs.
- 7 (seven) or fewer days of fluoroquinolone therapy in the 30 days preceding initiation of study drugs.
- Age >= 18 years
- Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix B)
Show all 15Show fewer
- Signed informed consent
- Women of child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
- Laboratory parameters done within 14 days prior to, enrollment:
- Serum or plasma alanine aminotransferase (ALT) activity ≤ 3 times the upper limit of normal
- Serum or plasma total bilirubin level ≤ 2.5 times the upper limit of normal
- Serum or plasma creatinine level ≤ 2 times the upper limit of normal
- Complete blood count with hemoglobin level of at least 7.0 g/dL
- Complete blood count with platelet count of at least 100,000/mm3
- Negative pregnancy test (women of childbearing potential)
Who cannot join
- Pregnant or breast-feeding
- Known intolerance or allergy to any of the study drugs
- Concomitant disorders or conditions for which isoniazid (INH), rifamycins, pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
- Current or planned therapy, during the intensive phase of TB therapy, with combination antiretroviral therapy for HIV, or with cyclosporine or tacrolimus. Cyclosporine and tacrolimus have unacceptable interactions with rifamycins.
- Pulmonary silicosis
- Central nervous system TB
- Weight < 40 kg or > 85 kg
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States23 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
Boston Medical Center
Boston, Massachusetts, 02118
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27710
University of North Texas Health Science Center
Fort Worth, Texas, 76104
Hines VA Medical Center
Hines, Illinois, 60141
Houston Veterans Administration Medical Center
Houston, Texas, 77030
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205
LA County/USC Medical Center
Los Angeles, California, 90033
University of Southern California Medical Center
Los Angeles, California, 90033
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637
Veterans Administration Tennessee Valley Health Care System
Nashville, Tennessee, 37232
Columbia University/Presbyterian Medical Center
New York, New York, 10032
Harlem Hospital, Columbia University
New York, New York, 10037
New Jersey Medical School
Newark, New Jersey, 07107-3001
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284
University of California at San Diego
San Diego, California, 92103
University of California, San Francincisco
San Francisco, California, 94110
Seattle King County Health Department
Seattle, Washington, 98104
Washington DC Veterans Administration Medical Center
Washington D.C., District of Columbia, 20422
Canada2 sites
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada
University of Manitoba
Winnepeg, Manitoba, R3A 1R8
Brazil1 site
Hopital Universitario Clementino Fraga Filho
Rio de Janeiro, 2194.590
South Africa1 site
Nelson R Mandela School of Medicine
Durban, KwaZulu-Natal
About this study
Official title: TBTC Study 29: Evaluation of a Rifapentine-containing Regimen for Intensive Phase Treatment of Pulmonary Tuberculosis
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
Participants were randomized to receive either a standard rifampin-based regimen (RHZE) or a rifapentine-substituted regimen (PHZE). An extension study evaluated higher daily doses of rifapentine (10, 15, and 20 mg/kg).
The primary endpoint was sputum culture conversion at 8 weeks. Secondary outcomes included time to culture conversion, safety, and treatment discontinuation.
Read the detailed description
This Phase 2, prospective, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
In the main study, adult participants with suspected pulmonary tuberculosis were randomized to receive either a standard intensive-phase regimen consisting of rifampin, isoniazid, pyrazinamide, and ethambutol (RHZE), or an experimental regimen in which rifapentine (10 mg/kg) was substituted for rifampin (PHZE). Treatment was administered five days per week under direct observation for 8 weeks.
The study extension evaluated higher daily doses of rifapentine (10 mg/kg, 15 mg/kg, and 20 mg/kg) in combination with isoniazid, pyrazinamide, and ethambutol, compared to the standard rifampin-based regimen. In the extension, treatment was administered seven days per week.
The primary efficacy endpoint was the proportion of participants with negative sputum cultures at completion of the intensive phase. Secondary endpoints included time to culture conversion, safety and tolerability, and rates of treatment discontinuation.
Following completion of the intensive phase, participants received standard continuation-phase tuberculosis treatment per guidelines.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- rifapentine, rifapentine 10 mg/kg, rifapentine 15 mg/kg, rifapentine 20 mg/kg
- Keywords
- pulmonary tuberculosis, treatment
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifapentineDrug
Also called Rifadin
tablet, 10 mg/kg, daily, 8 weeks
rifapentine 10 mg/kgDrug
Also called Priftin
tablet, 10 mg/kg, daily, 8 weeks
rifapentine 15 mg/kgDrug
Also called Priftin
tablet, 15 mg/kg, daily, 8 weeks
rifapentine 20 mg/kgDrug
Also called Priftin
20 mg/kg, daily, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard TB Treatment (RHZE): Rifampin 10 mg/kg Daily for 8 Weeks | Active comparator | rifampin, isoniazid, pyrazinamide, ethambutol Receives: Drug: rifapentine |
| Rifapentine 10 mg/kg Daily TB Treatment (PHZE) for 8 Weeks | Experimental | rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol Receives: Drug: rifapentine 10 mg/kg |
| Rifapentine 15 mg/kg Daily TB Treatment (PHZE) for 8 Weeks | Experimental | rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol Receives: Drug: rifapentine 15 mg/kg |
| Rifapentine 20 mg/kg Daily TB Treatment (PHZE) for 8 Weeks | Experimental | rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol Receives: Drug: rifapentine 20 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Negative Sputum Culture at 8 Weeks
Proportion of participants with negative Mycobacterium tuberculosis sputum cultures at completion of the 8-week intensive phase of treatment.
Measured: 8 weeks.
Participants Who Discontinued Treatment During Intensive Phase
Number of participants who permanently discontinued assigned study treatment for any reason during the first 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Susan Dorman, MD, Principal investigator, Johns Hopkins UniversityNeil Schluger, MD, Study chair, Columbia UniversityJason Stout, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694629
- Sponsor's protocol ID
- CDC-NCHSTP-5399
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2008
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will not be made available.
Publications
Dorman SE, Goldberg S, Stout JE, Muzanyi G, Johnson JL, Weiner M, Bozeman L, Heilig CM, Feng PJ, Moro R, Narita M, Nahid P, Ray S, Bates E, Haile B, Nuermberger EL, Vernon A, Schluger NW; Tuberculosis Trials Consortium. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the tuberculosis trials consortium. J Infect Dis. 2012 Oct 1;206(7):1030-40. doi: 10.1093/infdis/jis461. Epub 2012 Jul 30.
PubMed 22850121Gewitz AD, Solans BP, Mac Kenzie WR, Heilig C, Whitworth WC, Johnson JL, Nsubuga P, Dorman S, Weiner M, Savic RM; Tuberculosis Trials Consortium of the Centers for Disease Control and Prevention. Longitudinal Model-Based Biomarker Analysis of Exposure-Response Relationships in Adults with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0179420. doi: 10.1128/AAC.01794-20. Epub 2021 Jul 12.
PubMed 34252302Jarsberg LG, Kedia K, Wendler J, Wright AT, Piehowski PD, Gritsenko MA, Shi T, Lewinsohn DM, Sigal GB, Weiner MH, Smith RD, Keane J, Jacobs JM, Nahid P. Nutritional markers and proteome in patients undergoing treatment for pulmonary tuberculosis differ by geographic region. PLoS One. 2021 May 5;16(5):e0250586. doi: 10.1371/journal.pone.0250586. eCollection 2021.
PubMed 33951066Weiner M, Gelfond J, Johnson-Pais TL, Engle M, Johnson JL, Whitworth WC, Bliven-Sizemore E, Nsubuga P, Dorman SE, Savic R; Pharmacokinetics/Pharmacodynamics Group of Tuberculosis Trials Consortium. Decreased plasma rifapentine concentrations associated with AADAC single nucleotide polymorphism in adults with tuberculosis. J Antimicrob Chemother. 2021 Feb 11;76(3):582-586. doi: 10.1093/jac/dkaa490.
PubMed 33374006Dorman SE, Savic RM, Goldberg S, Stout JE, Schluger N, Muzanyi G, Johnson JL, Nahid P, Hecker EJ, Heilig CM, Bozeman L, Feng PJ, Moro RN, MacKenzie W, Dooley KE, Nuermberger EL, Vernon A, Weiner M; Tuberculosis Trials Consortium. Daily rifapentine for treatment of pulmonary tuberculosis. A randomized, dose-ranging trial. Am J Respir Crit Care Med. 2015 Feb 1;191(3):333-43. doi: 10.1164/rccm.201410-1843OC.
PubMed 25489785