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

Not Applicable

• Conditions: -B200 HIV disease resulting in mycobacterial infection; HIV disease resulting in mycobacterial infection; B200

• Registration Number: PER-039-07
• Lead Sponsor: ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. HIV-1 infection.
2. TB confirmed or probable.
3. X-ray of the chest within 30 days prior to study entry.
4. Current TB treatment based on rifampicin and other rifamycin derivatives initiated within 14 days prior to admission to the study.
5. Amount of CD4 cells <200 cells / mm3 obtained within 30 days before admission to the study in any of the laboratories approved by DAIDS.
6. The following laboratory values ​​obtained within 14 days prior to admission to the study: a) Absolute number of neutrophils ≥ 500 cells / mm3. b) Hemoglobin ≥ 7.0 g / dL. c) Amount of platelets ≥ 50,000 / mm3. d) Estimated creatinine clearance ≥ 60 mL / min. e) AST (SGOT), ALT (SGPT), bilirubin, and alkaline phosphatase ≤ 5 x ULN.
7. Female participants with reproductive potential with a serum or negative urine pregnancy test within 7 days before admission to the study.
8. All participants must agree to avoid any conception process.
9. Female participants who are participating in a sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception.
10. Ability to swallow medications orally.
11. Male and female participants, aged ≥ 13 years.
12 The ability and availability of the participant or the tutor / representative to give informed consent.

Exclusion Criteria

1. Having received at any time prior to admission to the study for> 7 days of cumulative treatment with any ARV or treatment during any period of time with 2 or more ARVs in combination.
2. Breastfeeding.
3. Allergy / sensitivity to any study drug or its formulations.
4. Having a prior history of documented multidrug resistant TB.
5. Having received any research or chemotherapy therapy within 30 days prior to admission to the study.
6. Anticipated reception of any of the prohibited medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified