An Adaptive Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: HIV Infections; Multi Drug Resistant Tuberculosis

• Registration Number: NCT05633056
• Lead Sponsor: Columbia University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Culture or molecular test positive for MTB<br><br> 2. Molecular test positive for HIV or a documented HIV positive history<br><br> 3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional<br> testing consistent with at least rifampicin-resistant TB,<br><br> 4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of<br> enrollment and first-time being treated with BDQ<br><br> 5. On treatment with Antiretroviral Therapy (ART) regimen, including<br> dolutegravir-containing combination Antiretroviral Therapy regimen (i.e.<br> Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,<br><br> 6. Capacity for informed consent in either isiZulu or English<br><br>Exclusion Criteria:<br><br> 1. Pregnancy<br><br> 2. Prisoners<br><br> 3. Discretion of IOR or clinician

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biological outcome;Clinical outcome;Biological outcome;Clinical outcome;Biological outcome