A Randomized Trial of Highly Active Antiretroviral Therapy in Acute/Early HIV Infection

About the Study

The purpose of this study is to evaluate the effectiveness of an experimental strategy for treating HIV. The study aims to determine whether an immediate course of one year of highly active antiretroviral therapy (HAART) slows the progression of HIV disease in adults who have been recently infected with HIV.

Each participant will be randomly assigned to one of two study groups. Those assigned to the Immediate Treatment group will start taking anti-HIV medications right away and continue to do so for one year. Those assigned to the Deferred Treatment group will not receive immediate treatment, but will be followed closely and start taking anti-HIV medications only if their immune system is not functioning well and they meet the standard of care guidelines for treating HIV.

The study will evaluate the effectiveness of the immediate treatment strategy by comparing the HIV viral load and CD4 cell counts of treated versus untreated study participants at two and three years following study entry. Within the Immediate Treatment group, the study will also compare the viral load and CD4 cell counts of participants who enrolled within 2 months of being infected with HIV (called "acute seroconverters") versus participants who enrolled between 2 to 12 months after initial HIV infection (called "early seroconverters").

View the Study Consent Form

If you have any questions regarding the study, please email or call

Linda Apuzzo  (410) 614-7796 or

Hejab Imteyaz (410) 502-8053