Clinical trial NCT00023426: TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
Official title: TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
Keywords: tuberculosis
tb
rifapentine
safety
dose
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2001-09-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind study of the tolerability of three different doses of rifapentine

Detailed description: Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

Eligibility criteria: Inclusions:

1. Drug susceptible culture-positive tuberculosis
2. Adequate induction therapy
3. Age \>18
4. Normal screening labs
5. Karnofsky \>=60
6. Informed consent
7. Birth control if of child bearing potential

Exclusions:

1. SilicoTB
2. Skeletal or CNS TB
3. Pregnant or breastfeeding
4. Intolerance to INH or rifamycins
5. Over 70 days TB treatment just prior to enrollment

Primary outcomes:
measure: Proportion of patients who fail to complete therapy in each of the dosing groups
Secondary outcomes:
measure: 1. Rate of serious adverse events in each of the dosing groups
measure: 2. Rate of total adverse events in each of the groups
measure: 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Health System
state: Arkansas
city: Los Angeles
country: United States
facility: LA County/USC Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Denver Department of Public Health and Hospitals
state: Colorado
city: Washington
country: United States
facility: Washington, D.C. VAMC
state: District of Columbia
city: Chicago
country: United States
facility: Chicago VA Medical Center (Lakeside)
state: Illinois
city: Hines
country: United States
facility: Hines VA Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University/Presbyterian Medical Center
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Nashville VA Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: San Antonio
country: United States
facility: Audi L. Murphy VA Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle King County Health Department
state: Washington
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Montreal
country: Canada
facility: Montreal Chest Institute McGill University
state: Quebec
Study officials:
affiliation: Centers for Disease Control & Prevention
name: Naomi Bock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bock NN, Sterling TR, Hamilton CD, Pachucki C, Wang YC, Conwell DS, Mosher A, Samuels M, Vernon A; Tuberculosis Trials Consortium, Centers for Disease Control and Prevention, Atlanta, Georgia. A prospective, randomized, double-blind study of the tolerability of rifapentine 600, 900, and 1,200 mg plus isoniazid in the continuation phase of tuberculosis treatment. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1526-30. doi: 10.1164/rccm.200201-047OC.