Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment
Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Protocol Summary
Title: Evaluation of safety and efficacy of two different once daily anti-retroviral
treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and
tuberculosis - Randomized Controlled Clinical Trial
Phase: Phase III trial
Population: 180 HIV-1 positive patients with tuberculosis
Number of Sites: Four.
1. Tuberculosis Research Centre, Chennai
2. Government Medical College, Vellore
3. Government Hospital of Thoracic Medicine, Tambaram
4. Government Rajaji Hospital, Madurai
Study Duration: 26 months including 24 months of ART.
Study Objectives:
Primary Objective To compare the efficacy and safety of two different once-daily
anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in
patients with HIV-1 and tuberculosis, by using virologic end points.
Secondary Objective To compare the efficacy of antiretroviral treatment given under partial
supervision with unsupervised treatment (once a month supply).
Phase:
Phase 3
Details
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborators:
Indian Council of Medical Research National AIDS Control Organisation