A5381

Not Applicable

• Conditions: HIV/AIDS; Tuberculosis

• Registration Number: PACTR202006835180506
• Lead Sponsor: AIDS Clinical Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria
1.Receiving care at a PEPFAR-supported site.
2 Documentation of HIV-1 infection acceptable to the local PEPFAR-supported
program to allow antiretroviral (ARV) treatment to be initiated or continued.
3 Age more than or equal to 10 years.
4 Ability and willingness of participant or legal guardian/representative to provide
informed consent to participate in the study.
5 Expectation that the participant will receive care within the local PEPFARsupported
program and will be able to be followed for study evaluations for at
least 6 months and ideally for 36 months.

Exclusion Criteria

Exclusion Criteria
1. Weight less than 30 kg.
2 For participants already on ART in Groups 1, 2, and 3, known to have had an
ART interruption encompassing the entire 14 day window (=14 consecutive days)
immediately prior to study entry.
3 For Group 3, if a participant is already taking TLD at the time of study entry, HIV-
1 RNA >1000 copies/mL within the past 9 months while taking TLD with no
subsequent HIV-1 RNA =1000 copies/mL.
4 Prior enrollment in any group in this study.
5 For Group 3 participants, already on concomitant TLD and RIF-containing TB
treatment prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified