Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
NCT00993148 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2014-09-05
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.
Conditions
- HIV-1 Infection
- HIV Infections
Interventions
- DRUG
-
maraviroc
150 mg tab by mouth once daily for 96 weeks
- DRUG
-
darunavir
800 mg tab by mouth once daily for 96 weeks
- DRUG
-
ritonavir
100 mg capsule by mouth once daily for 96 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
Tibotec, Inc
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Babafemi Taiwo, MD · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2013-04-30
- Completion
- 2013-04-30
Countries
- United States
Study Locations
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