Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection

About 6 months after infection, HIV viral load reaches a temporarily stable level known as
virus set point. Virus set point is different for each patient and can be a predictor for
disease progression. Preliminary studies indicate that early, short-term antiretroviral
therapy (ART) given to people newly infected with HIV may lead to lower virus set points and
preserved CD4 counts. However, the length of short-term treatment needed to balance the
possible adverse effects of ART with the achievement of lower virus set point is not yet
known. By lowering the virus set point and maintaining CD4 counts, the need for long-term
ART may be postponed. The purpose of this study is to determine the safety and efficacy of
a short course of ART on producing a lower virus set point in adults recently infected with
HIV.

This study will last at least 28 weeks. Participants will be randomly assigned to one of two
arms. Arm A will receive ART for 12 weeks as emtricitabine/tenofovir disoproxil fumarate
(TDF/FTC) daily and lopinavir/ritonavir (LPV/RTV) in tablet form twice daily. After 12
weeks, treatment will be interrupted unless the CD4 count is measured to be less than 350
cells/mm^3 on two consecutive occasions during treatment interruption. If that occurs
therapy will be resumed. Participants in Arm B will receive no treatment until CD4 counts
drop below 350 cells/mm^3, indicating ART is needed. Study visits will occur at study entry,
at Weeks 2 and 4, and every 4 weeks thereafter. At each study visit, a physical exam, blood
collection, and completion of an adherence questionnaire will occur. Participants are
encouraged to enroll in a related substudy that will evaluate HIV viral load in genital
secretions.