A5290, A 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
Study Location:
India
Topic:
Tuberculosis and HIV
Clinicaltrials.gov Link:
https://clinicaltrials.gov/ct2/show/NCT01601626?term=A5290&rank=1
Enrollment:
Closed
Trial Period:
Completed
Rifampin (RIF), the cornerstone of TB treatment, has very problematic drug-drug interactions with PIs. The use of relatively high doses of ritonavir appear necessary to overcome this interaction, but it is unclear whether the co-treatment regimen of RIF-based TB treatment and double-dose PI-based ART will be safe and tolerable for patients with HIV-related TB and effective in treating both HIV and TB.
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No