The vertical transmission of HIV-1 infection from mother to infant can be reduced by at least two-thirds using simple preventive anti-retroviral (ARV) drug regimens. Nevertheless, in developing countries, at least 10-12% of children born to HIV-1 infected mothers will still be HIV-1 infected. In developed countries the management of these children with anti-retroviral treatment (ART) and prophylaxis against opportunistic infections has significantly improved survival. However even in these countries issues of adherence, resistance, toxicities and cost remain a challenge. Therefore implementation of such an intervention in resource-constrained countries will only be possible through novel strategies. Such strategies should be affordable and easy to implement. The objective is to examine whether ART commenced by 3 months of age, during the acute infection, and given for a short period of time will have a long-term benefit in terms of preventing immunological and clinical progression of HIV and will significantly improve outcome and whether it will be feasible and safe. This is a two center randomized, open label trial. The trial will have two parts. Part A: Infants with HIV infection and CD4%>25% at or before 12 weeks of age will be randomized in a 1:1:1 ratio to one of three arms. Arm 1: no treatment, Arm2: ART until first birthday (approx. 9 months), Arm 3 ART until second birthday (approx. 21 months). Part B: Infants with HIV infection and CD4%<25% at or before 12 weeks will all receive ART. They will be randomized to arms 2 and 3 only. Infants randomized to arm 1 will commence ART if they develop severe CDC stage B disease or stage C disease or if the CD4% falls to <20%. Antiretroviral therapy will be initiated during the first three months of life and interrupted at 1 or 2 years of age. A four-drug regimen will be used. The proposed duration of the study is five years. Enrollment will be completed in one year. Therefore the minimum follow up for a child will be 4 years. Any child who develops severe CDC Stage B or stage C disease or if the CD4% falls to<20% during the duration of the trial will be eligible for ART. For the primary objective a Kaplan and Meier Curve for the 3 arms will be constructed and compared 1 to 2 and 1 to 3 i.e. time to event analysis.
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