Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine given Daily for LTBI (ASTERoiD;TBTC Study 37)
Sponsor – U.S. Centers for Disease Control & Prevention (75D30121C10164)
Principal Investigator – John L. Johnson, MD, ÐÇ¿Õ´«Ã½
| Type of Study |
Open-label Phase III Clinical Trial |
|---|---|
| Design | Open-label, Multi-center, phase III randmomized controlled non-inferiority clinical trial with two arms |
| Project Site | Kampala, Uganda |
| Sample Size | A total of at least 1,120 participants (560/arm) at all study sites will be randomized. |
| Study Period | Individual participant duration of follow-up is 24 months. |
Goal of Study:
Assess the efficacy and safety of several regimens based on novel agents in the treatment of The primary objectives of this open-label Phase III clinical trial are to compare the safety and effectiveness of a six week regimen of daily rifapentine (6wP, the experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment of latent M. tuberculosis infection (LTBI). The latter will be the local standard of care rifamycin-based regimen. This trial will be conducted among persons with LTBI living in low, moderate and high tuberculosis (TB) incidence settings who are at increased risk of progression to TB and require treatment of LTBI.
Primary Objectives:
- Compare the safety of daily 6wP to a comparator arm of 12-16 week rifamycin-based treatment (3HP, 3HR, or 4R) for the prevention of TB in persons > 12 years old with LTBI.
- If safe, compare the effectiveness of daily 6wP to a comparator arm of 12-16 week rifamycin-based treatment (3HP, 3HR, or 4R) for the prevention of TB in persons > 12 years old with LTBI.
Secondary Objectives:
Among those treated with 6wP vs. the comparator arm (3HP, 3HR, or 4R), compare the:
- Proportion who complete assigned treatment (tolerability).
- Treatment completion will be assessed by both participant self-report and pill counts for those receiving self-administered therapy and by medication administration records for those receiving directly-observed therapy.
- Proportion with drug discontinuation for any reason.
- Proportion with any grade 3, 4, or 5 (i.e., death) adverse event during the time period of 6 months after enrollment
- Proportion with any grade 3, 4, or 5 (i.e., death) adverse event associated with study drug (ADR).
- Proportion who have died for any reason
- Proportion with hepatitis and non-hepatotoxic systemic drug reactions.
- Proportion with culture-confirmed or clinical TB regardless of age.
- Proportion with TB among those who complete assigned therapy (efficacy).
- Safety, tolerability, and effectiveness among participants with human immunodeficiency virus (HIV) infection.
- Safety, tolerability, and effectiveness in participants < 18 years old.