A Study for comparison of outcome of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis when the CD4 count is less than 250 Cells/mm3
- Conditions
- Health Condition 1: null- HIV InfectionTuberculosis
- Registration Number
- CTRI/2009/091/000511
- Lead Sponsor
- AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria:
HIV-infected
Confirmed or probable TB. More information on the criterion can be found in the protocol.
Chest x-ray within 30 days prior to study entry
Current rifampin- or other rifamycin-based TB treatment initiated within 14 days prior to study entry
CD4 count less than 200 cells/mm3 within 30 days prior to study entry
Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs
Able to swallow oral medications
Parent of guardian willing to provide informed consent, if applicable
Exclusion Criteria:
ART for longer than 7 days prior to study entry or treatment for any period of time with two or more antiretrovirals in combination. Participants who have taken nevirapine or zidovudine during pregnancy are not excluded.
Allergy or sensitivity to any of the study drugs or their formulations
History of multidrug-resistant TB
Receipt of any investigational therapy or chemotherapy within 30 days prior to study entry
Certain medications
Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the proportion of participants who have survived without AIDS progression by week 48 on the study ·Timepoint: Assessment at 48 weeks or earlier if the primary end point is noted,
- Secondary Outcome Measures
Name Time Method 1.Determine safety and tolerability of ART in participants being treated for TB, assessed by the proportion of participants with Grade 3 or higher toxicities and the proportion of participants changing/discontinuing ART because of toxicities or treatment failure <br/ ><br>·Identify predictors of mortality and other AIDS-defining illnesses <br/ ><br>Timepoint: 1.time point during the 48 weeks of followup in the study