Randomized Trial of When to Start Antiretroviral Therapy

In many resource-limited settings, antiretroviral therapy (ART) is not started until a patient's CD4 count drops below 200 cells/mm³ or clinical AIDS develops. To determine whether earlier ART initiation improves survival in such settings, investigators conducted a randomized, controlled trial in Haiti.

A total of 816 treatment-naive HIV-infected adults with CD4 counts between 200 and 350 cells/mm³ were enrolled. Patients randomized to “early” treatment initiated open-label lamivudine/zidovudine/efavirenz within 2 weeks of enrollment; those in the “standard” treatment group started the same regimen, but not until clinical AIDS developed or their CD4 counts fell to ≤200 cells/mm³. The median duration of follow-up was 21 months.

Twenty-nine pat…