Conditions: HIV-1 Infection HIV Infections
Keywords: Treatment naive
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.

Detailed description:

Arms:
arm 1: Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks

Interventions: intervention 1: maraviroc intervention 2: darunavir intervention 3: ritonavir
Intervention descriptions: intervention 1: 150 mg tab by mouth once daily for 96 weeks intervention 2: 800 mg tab by mouth once daily for 96 weeks intervention 3: 100 mg capsule by mouth once daily for 96 weeks

Protocol document: