Study name : Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection
Research network (Code) : A5279
Principle investigator : Professor Khuanchai Supparatpinyo, MD
Co-PI : Dr. Patcharaphan Sugandhavesa
Collaborators :
AIDS Clinical Trial Group :ACTG Network
Funding agency :
The National Institute of Allergy and Infectious Diseases :NIAID
Study sites:
More than 50 CRS worldwide include North-Amarica, Latin-America, Africa and Asia (Thailand and India)
Study start
Open : enrolled the first participant on 23 May 2012 , closed to accrual on 14 Nov 2014
Target : HIV-1-infected males and females at non-US sites, aged ≥18 years, 3000 participants.
Study design
This study is a multicenter, randomized, open-label, phase III clinical trial of an experimental TB treatment regimen (Arm A) of RPT/INH daily for 4 weeks compared to a standard TB treatment regimen (Arm B) of INH daily for 36 weeks in HIV-infected participants who do not have evidence of active TB. Randomization will be 1:1.
|
Weeks |
ArmA (Experimental) |
Arm B (Standard) |
|
1 – 4 |
RPT weight-based dosing*/ INH 300 mg daily |
INH 300 mg daily |
|
5 – 36 |
No treatment |
INH 300 mg daily |
|
37-close to follow-up |
No treatment |
No treatment |
Objective
1.Primary objective
To compare the efficacy of a 4-week daily regimen of weight-based RPT/INH to a standard 9-month (36 week) daily INH regimen for TB prevention in HIV-infected individuals.
2. Secondary objective
2..1 To compare safety and tolerability of the regimens
2..2 To compare overall and non-TB mortality rates among participants receiving the two regimens
2.3 To compare adherence rates in the two regimens
2.4 To investigate patterns of antibiotic resistance among Mycobacterium tuberculosis (MTB) isolates in participants failing prophylaxis
3. supportive/exploratory objective
To inform public health policy by comparing estimated costs and cost-effectiveness of the two regimens in various populations
To investigate the effect of RPT on efavirenz (EFV) and nevirapine (NVP) plasma concentrations
To describe exposure-outcome relationships among EFV and NVP pharmacokinetic (PK) parameters and virologic failure, and safety and tolerance related to EFV and NVP
3.4 To describe exposure-outcome relationships among EFV and NVP pharmacokinetic (PK) parameters and virologic failure, and safety and tolerance related to EFV and NVP
Significance
HIV-infected people have an increased risk of developing active tuberculosis (TB). The standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of treatment may be as effective and potentially increase treatment adherence. This study will compare the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.
Progression
Interesting findings
Publications
N/A
Link to project’s web site
https://clinicaltrials.gov/ct2/show/NCT01404312?term=A5279&rank=1
https://www.actgnetwork.org/protocols/protocol_specific_search.aspx
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