A5290 RIFAMPIN-BASED TB TREATMENT VS. RIFABUTIN-BASED TB TREATMENT IN HIV

Not Applicable

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

• Registration Number: PER-047-14
• Lead Sponsor: El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-25
• Study Completion: 2017-01-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1.HIV-1 infection,
2.CD4+/CD8+ T-cell count obtained within 30 days prior to study entry
3.Confirmed or probable pulmonary or extrapulmonary TB
4..Chest x-ray within 30 days prior to study entry.
5.A PI-based ART regimen is required,
6.Laboratory values obtained within 14 days prior to study entry
7.For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to study
8.All participants must agree not to participate in a conception
9.Female participants who are participating in sexual activity that could lead to pregnancy must agree to use at least two reliable methods of contraception
10.Karnofsky performance score > 40 within 14 days prior to study entry
11.Men and women >18 years of age,
12.Ability to swallow oral medications.
13.Ability and willingness of participant to provide informed consent.

Exclusion Criteria

1.History of completed TB treatment and resolution of TB symptoms less than 1 year prior to the current TB episode at study entry
2.Documented multidrug-resistant tuberculosis (MDR TB) or extensively drug-resistant (XDR) TB.
3.Participants infected with a rifamycin resistant strain of TB as determined by HAIN GenoType MTBDR Plus line probe assay or, GeneXpert® MTB/RIF assay
4.Receipt of more than 28 cumulative days of anti-TB treatment for the current TB episode prior to study entry.
5.Active drug or alcohol use or dependence that, in the opinion of the site investigator
6.Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
7.Pregnant or breastfeeding.
8.Anticipated receipt of any of the prohibited medications
9..Known intolerance/allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
10.History of close contact with known MDR or XDR TB patients at any time prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified