Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients
Overview
- Phase
- Phase 3
- Intervention
- Early versus intermediate versus late initiation of ART
- Conditions
- HIV Infections
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
- Enrollment
- 642
- Locations
- 1
- Primary Endpoint
- To measure the incidence of progression to AIDS defining illness or mortality
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV infected patients co-infected with TB
- •Receiving any one of the standard anti-TB therapy regimens
- •All patients must agree to use contraception since they will be on efavirenz.
Exclusion Criteria
- •Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded
Arms & Interventions
1 - Early integrated-therapy group
antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment
Intervention: Early versus intermediate versus late initiation of ART
2 - Late integrated-therapy group
antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment
Intervention: Early versus intermediate versus late initiation of ART
3 - Sequential-therapy group
Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment
Intervention: Early versus intermediate versus late initiation of ART
Outcomes
Primary Outcomes
To measure the incidence of progression to AIDS defining illness or mortality
Time Frame: 18 months
Secondary Outcomes
- A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms(18 months)