NCT00398996

A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients

Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (actual)
• Sponsor: Centre for the AIDS Programme of Research in South Africa · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients: Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.

Conditions

• HIV Infections
• Tuberculosis

Interventions

Type	Name	Description
DRUG	Early versus intermediate versus late initiation of ART	Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2006-11-14
• Last updated: 2011-03-24

Locations

1 site across 1 country: South Africa