Background The optimal time to start antiretroviral therapy (ART) for HIV–infected adults in resource limited settings with a CD4+ T cell count of 200 – 350 cells per mm3 remains uncertain. Methods We conducted a randomized, open label, trial of early versus standard ART initiation in HIV-infected adults with no history of an AIDS illness and a confirmed CD4+ T cell count between 200 and 350 cells per mm3 in Haiti. The primary study end point was survival. Participants in both groups received monthly follow up, isoniazid and trimethoprim-sulfamethoxazole prophylaxis, and nutritional support. The early treatment group initiated zidovudine, lamivudine, and efavirenz within two weeks of enrollment. The standard group started the same ART regimen when participants developed a CD4+ T cell count ≤ 200 cells/mm3 or clinical AIDS. Results Between 2005 and 2008, 816 participants, 408 per group, were enrolled and followed for a median of 21 months. The CD4 T cell count at enrollment was ~ 280 cells per mm3 in both groups. There were 23 deaths in the standard group and 6 in the early group, p=0.0011, hazards ratio 4.0, 95% CI 1.6 to 9.8. There were 36 incident tuberculosis cases in the standard group and 18 in the early group, p = 0.0125, hazard ratio 2.0, 95% CI 1.2 to 3.6. Conclusions Early ART decreased mortality and incident tuberculosis infection. Access to ART should be expanded to all HIV–infected adults with a CD4+ T cell count < 350 cells per mm3, including those from resource limited settings.

This cost-effectiveness study comparing early versus standard antiretroviral treatment (ART) for HIV, based on randomized clinical trial data from Haiti, reveals that the new WHO guidelines for early ART initiation can be cost-effective in resource-poor settings.