drugset
drugset / Trial / NCT01601626

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

NCT01601626 ↗

Phase 2 Terminated 71 enrolled Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART). This study compared three alternative co-treatment options among participants in high TB endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a PI together with rifabutin-based anti-TB treatment.

Timeline

Start
2013-07-13
Primary completion
2017-01-19
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Lopinavir/Ritonavir Unknown 400 mg Oral
Subject Lopinavir/Ritonavir Unknown 800 mg Oral
Subject Raltegravir Other / unclassified 400 mg Oral
Subject Rifabutin Small molecule 150 mg Oral
Comparator Rifampin Small molecule 450 mg Oral
Comparator Rifampin Small molecule 600 mg Oral
Background Ethambutol Small molecule 15 mg/kg Oral
Background Ethambutol Small molecule 20 mg/kg Oral
Background Isoniazid Small molecule 300 mg Oral
Background Pyrazinamide Small molecule 20 mg/kg Oral
Background Pyrazinamide Small molecule 30 mg/kg Oral
Background Pyridoxine Unknown 25 mg Oral

Indications

HIV infectious disease tuberculosis