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

AA5290 Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis Treatment with or without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-047-14

Enrollment

Registered

2014-11-25

Start date

2014-11-28

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Arm: LPV 400 mg/RTV 100 mg twice daily (BID) + two NRTIs. •Anti-TB therapy: Isoniazid (INH) 300 mg daily, RBT 300 mg daily, then 150 mg daily upon initiation of ART, ethambutol (EMB) daily, pyrazin

INH, RBT 150 mg daily (or the adjusted dose determined by PK testing), and pyridoxine will continue through week 24 for a minimum total duration of 24 weeks, and may continue beyond 24 weeks to a maxi

•After completion of TB treatment, LPV/r + two NRTIs will be continued with LPV/r at standard dosing (400mg/100mg BID) through week 72. Arm B: LPV 800 mg/RTV 200 mg BID + two NRTIs. •Anti-TB th

INH, RIF, and pyridoxine will continue through week 24 for a minimum total duration of 24 weeks, and may be continued beyond 24 weeks to a maximum of 48 weeks at the discretion of the primary clinicia

INH, RBT 150 mg daily (or the adjusted dose determined by PK), and pyridoxine will be continued through week 24 for a minimum total duration of 24 weeks, and may be continued beyond 24 weeks to a maxi

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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.

Countries

Brazil, Kenya, Peru, South Africa

Contacts

Public ContactJorge Alave

ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION

jalave@impactaperu.org2067800

Outcome results