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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Quest Clinical Research
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
CORECenter
Chicago, Illinois, United States
Percentage of Participants With Plasma HIV-1 RNA >50
Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL
Time frame: 24 weeks
Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA \> 50 copies/mL) or off study treatment regimen (composite end point)
Time frame: 24 weeks
Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL
Percentage of participants with confirmed plasma HIV-1 RNA level \>50 copies/mL
Time frame: 48 weeks
Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher
Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen
Time frame: 96 weeks
Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES
Time frame: At study entry and at the time of virologic failure
Drug Adherence, Number of Participants With Missed Doses
Drug adherence, assessed as number of participants with missed doses over four-day recall
Time frame: Week 24
Trough Concentrations (Ctrough) of Maraviroc
Average trough concentration (Ctrough) of maraviroc
Time frame: 24 hours
Median CD4 Count Change From Baseline
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University of Nebraska
Omaha, Nebraska, United States
Median changes from baseline in peripheral CD4+ T-cell count
Time frame: 96 weeks
Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL
Proportion of participants with confirmed plasma HIV-1 RNA level \>50 copies/mL
Time frame: 96 weeks