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.

BackgroundAttrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.Methods and findingsWe conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.ConclusionsSame-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease.Trial registrationThis study is registered with ClinicalTrials.gov number NCT01900080

This report documents the feasibility of effective antiretroviral therapy in a large number of patients in an impoverished country. Overall, the outcomes are similar to those in the United States. These results provide evidence in support of international efforts to make antiretroviral therapy available to patients with AIDS in developing countries.

Thomas Campbell and colleagues report findings of a randomized trial conducted in multiple countries regarding the efficacy of antiretroviral regimens with simplified dosing.