HIV-1 Infections Clinical Trial
Official title:
A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last
decade, current first-line ART regimens are imperfect. The ideal combination, unlike some
current first-line options, would have uncompromised efficacy in the presence of transmitted
drug-resistant variants. The primary purpose of this study is to estimate the cumulative
proportion of ART-naive participants experiencing virologic failure at or prior to week 24
after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).
The study will last 52 weeks. All participants will follow the same treatment schedule and
take RAL plus DRV/RTV orally daily for the duration of the trial.
After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and
52. Medical/medication history, blood and urine collection, and liver function tests will
occur at screening. A targeted physical exam and concomitant medications history will occur
at all study visits. Blood and urine collection and liver function tests will occur at most
study visits. For females, a pregnancy test will occur at screening and study entry.
RAL and DRV were provided by the study. RTV was not provided by the study.
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