TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment

Completed · Phase 2

Conditions studied: Pulmonary Tuberculosis

In brief

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.

Key facts

Study ID

NCT00694629

Run by

Centers for Disease Control and Prevention

People needed

334

Starts

2008-12-01

Expected to finish

2013-12-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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)

You may not qualify if…

• 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

Where it is running

• Central Arkansas Veterans Health System — Little Rock, Arkansas, United States
• LA County/USC Medical Center — Los Angeles, California, United States
• University of Southern California Medical Center — Los Angeles, California, United States
• University of California at San Diego — San Diego, California, United States
• University of California, San Francincisco — San Francisco, California, United States
• Denver Department of Public Health and Hospitals — Denver, Colorado, United States
• Washington DC Veterans Administration Medical Center — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Chicago VA Medical Center (Lakeside) — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Hines VA Medical Center — Hines, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• New Jersey Medical School — Newark, New Jersey, United States
• Columbia University/Presbyterian Medical Center — New York, New York, United States
• Harlem Hospital, Columbia University — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Nashville VA Medical Center — Nashville, Tennessee, United States
• Veterans Administration Tennessee Valley Health Care System — Nashville, Tennessee, United States
• University of North Texas Health Science Center — Fort Worth, Texas, United States
• Houston Veterans Administration Medical Center — Houston, Texas, United States
• Audi L. Murphy VA Hospital — San Antonio, Texas, United States
• Seattle King County Health Department — Seattle, Washington, United States
• Hopital Universitario Clementino Fraga Filho — Rio de Janeiro, Brazil
• University of Manitoba — Winnepeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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