Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals

DESIGN Randomized, placebo controlled, double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy. DURATION 42 days. SAMPLE SIZE and POPULATION 27 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell counts ≥ 350 cells/mm3. REGIMEN Subjects will be randomized 1:1:1 to receive two different doses of aprepitant (Emend®) or placebo. * Arm A: Aprepitant placebo * Arm B: Aprepitant 125 mg QD * Arm C: Aprepitant 250 mg QD HYPOTHESIS AND STUDY OBJECTIVES * Hypothesis : Aprepitant is safe, tolerable, and has antiviral activity in HIV infected individuals. * Primary Objectives: * To assess the safety and tolerability of aprepitant for 2 weeks at two different doses. * To assess the response of plasma HIV-1 RNA to two different doses of aprepitant compared with baseline. * Secondary Objectives: * To investigate the course and duration of antiretroviral response to 2 different doses of aprepitant given over a 14-day period. * To evaluate the dose-response and pharmacokinetic and pharmacodynamic relationship between viral RNA change and aprepitant plasma levels. * To evaluate aprepitant effects on CD4+ and CD8+ T-cell counts, circulating SP levels, natural killer cell number and function and CCR5 expression in peripheral PBMCs. * To evaluate the effects of aprepitant in the viral tropism and envelope sequence of the main HIV-1 population of the participants. * To assess viral drug susceptibility in conjunction with baseline coreceptor tropism phenotype and changes in coreceptor phenotype after the exposure to aprepitant. * To evaluate aprepitant effects on fasting plasma glucose, insulin, HDL, free fatty acids, and triglyceride concentrations after 14 days of treatment. * To provide preliminary description of any change from baseline in sleep quality, anxious mood, depressed mood and neurocognitive measures after 2 weeks of aprepitant therapy.