Primary Outcome Measures:
- Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of the plasma viral load in all treated vs. untreated patients [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
- Comparison of the CD4 lymphocyte count in all treated vs. untreated patients [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
- Comparison of the plasma viral load in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
- Comparison of the CD4 lymphocyte count in patients treated in the acute vs. early stage of infection [ Time Frame: At Months 24 and 36 ] [ Designated as safety issue: No ]
- Toxicity of HAART in all treated patients [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Estimated Enrollment:
180
Study Start Date:
February 2005
Estimated Study Completion Date:
August 2011
Estimated Primary Completion Date:
August 2009 (Final data collection date for primary outcome measure)
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.