Conditions: HIV Infections
Keywords: HIV Acute/Early Seroconverters Acute Infection Treatment Naive Primary HIV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 113
Healthy volunteers: no

Brief summary:
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.

Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

Detailed description:
Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).

This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.

Arms:
arm 1: Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated. arm 2: Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated.

Interventions: intervention 1: Highly active antiretroviral therapy (HAART)
Intervention descriptions: intervention 1: Regimens will be assigned by investigators

Protocol document: