Background:  Recently, through the Global Fund (MAP) or PEPFAR, ART was made available without charge to AIDS patients in sub-Saharan Africa. The purpose of this investigation is to assess the early effectiveness of treatment in this context.

Methods:  Between January 2004 and June 2005, 636 HIV-infected ART-naïve adults were consecutively enrolled into a cohort at the Infectious Diseases Institute of the Makerere University in Kampala, Uganda. At enrollment, all individuals were evaluated by questionnaire, physical examination, and laboratory testing, including CD4 count and HIV viral load. Based on the stage of HIV infection, a total of 538 individuals began at enrollment 1 of 2 ART regimens:  stavudine, lamivudine, and nevirapine (MAP) or combivir and efavirenz (PEPFAR). All cohort members were evaluated and given medications monthly. HIV RNA levels and CD4 counts were repeated every 6 months.

Results:  Of 538 patients who began ART at enrollment, mean age was 37 years (20 to 70); 69% were female; mean weight was 54.7 kg; 36%, 54%, and 10% were WHO stage 4, 3, and 2, respectively. The results of HIV RNA and CD4 testing at enrollment and 6 months later are shown in the table. Complete data from the 6-month visit are available for 365 patients. For 85.5% of the patients, HIV RNA was < 401 copies/ml after six months on therapy. No differences were detected in the age, gender, ART regimen (MAP vs PEPFAR), or baseline WHO stage of those with HIV RNA <401 copies/mL compared with the 53 with HIV RNA >400 copies/mL; however, the baseline HIV RNA was lower (median 286,132) in the 312 with HIV RNA <401 copies/mL compared with the 53 (median 300,486).

Conclusions:  These data demonstrate the early virological, immunologica,l and clinical effectiveness of ART provided in this sub-Saharan African HIV clinic.