Clinical trial NCT00414518
Conditions: HIV Infections
Keywords: Acute Infection Early HIV Infection Short-Term Antiretroviral Therapy Treatment Interruption Antiretroviral Drug (ARV) ART
Sponsor: University of Colorado, Denver
Start date: 2007-01-01; Completion date: 2010-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.

Detailed description:
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 cluster of differentiation 4 (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.

Arms: arm 1: Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed. arm 2: Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
Interventions: intervention 1: Tenofovir disoproxil fumarate/Emtricitabine intervention 2: Lopinavir/Ritonavir
Intervention descriptions: intervention 1: 300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily intervention 2: Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily

Protocol documents: