Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis STRIDE

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-074-09
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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.
• Receipt of 1-14 cumulative days of rifampin- or other rifamycin-based TB treatment that was initiated within 28 days prior to study entry.
• CD4 count less than 250 cells/mm^3 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.
• Karnofsky performance score =>20 at time of study entry.

Exclusion Criteria

• ART for longer than 7 cumulative days prior to study entry or treatment for any period of time with one or more antiretrovirals. Participants who have taken ART during pregnancy or for occupational exposure 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.
• Breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.<br><br>Measure:Percent of Participants Who Survived Without AIDS Progression.<br>Timepoints:Through week 48<br>