drugset / Trial / NCT03089983

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

NCT03089983 ↗

RandomizedParallel-groupOpen-labelHealth-services research

Summary

The purpose of this study is to conduct empiric studies of tuberculosis (TB) among people in prison with and without a history of opioid dependence. A RCT of latent TB infection prevention strategies among HIV+ and HIV- prisoners with high prevalence of hepatitis C (HCV) using standard 40-week daily isoniazid (40H) vs short-course weekly isoniazid + rifapentine (12HR). Investigators will also use this data, and publicly available data to complete agent-based modeling for comparative and cost-effectiveness of various TB screening and treatment strategies among prisoners.

Timeline

Start
2017-08-21
Primary completion
2024-04-04
Completion
2024-04-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Standard Isoniazid (INH) for 26 Weeks vs Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks; p = 0.08; t-test, 2 sided NCT03089983 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoniazid Small molecule — —
Subject Rifapentine Small molecule — —