The main purpose of this study is to find out if starting anti-HIV medicines (ARVs) within 48 hours of birth can make it possible for babies who are infected with HIV to control HIV so well that HIV cannot be detected in their blood. As of now, when children with HIV start taking ARVs, they usually need to keep taking them for life. For newborn babies who start ARVs very soon after birth, it might be possible to later stop taking ARVs for a prolonged period of time and still stay healthy.  This has only been seen in one baby so far. That child started ARVs soon after birth, then stopped ARVs, and was able to stay healthy, with no HIV detected in the blood, for more than two years.  About 27 months after stopping ARVs, HIV was detected in this child’s blood and the child restarted ARVs.  The amount of HIV in the child’s blood quickly dropped and the child has remained healthy.  This study is being done to find out if this can be seen in other babies who start ARVs very soon after birth.  This study is also looking at the levels of ARVs that are safe and work well for babies this young.

Kericho site plan to enroll upto 60 mothers and their infants into this study.

The ability of the HIV virus to establish latency in the infected individual is a major obstacle to curing the infection. HIV latency in long lived cells, particularly resting memory CD4+ T cells, promotes viral quiescence, which renders latently infected CD4+ memory cells non-susceptible to antiretroviral drugs or HIV-specific immunity. A case of prolonged HIV remission was reported in a child who was treated with three drug ART by 31 hours of life for high-risk HIV-exposure from untreated maternal infection. Longitudinal follow-up revealed eventual return of viremia at 46 months of age after being off ART for nearly 2.3 years. The re-emergence of viremia in this child provides further support that viral remission is achievable in perinatal infection through time-limited very early ART, although the exact timing of ART initiation and duration of ART required to achieve cure is unknown and will be studied in P1115. This study (P1115) will address the hypothesis that very early therapy in HIV-infected neonates substantially limits the establishment of HIV reservoirs to permit long-term control of HIV replication off ART, leading to HIV remission. This protocol is designed to focus on the effect of starting ART within the first 48 hours of life on likelihood of achieving HIV remission in in utero infection. The primary objective is to assess HIV remission among HIV-infected neonates who initiate ART within 48 hours of birth. Infants and their mothers will be enrolled in two cohorts; Cohort 1 being infants≤ 48 hours of age at high risk for HIV infection (i.e. born to a mother with confirmed or presumed HIV infection and mother did not receive ARVs during the current pregnancy or mother first identified as HIV-infected in labor or postpartum). Cohort 2 will be infants ≤ 10 days of age who are HIV-infected and ART-started within the first 48 hours of life. The study consists of four steps: Step 1 (evaluation and initial treatment of high-risk infants), Step 2 (management of subjects with confirmed HIV infection), HIV-infected infants who meet defined eligibility criteria will undergo ART cessation at or after Step 2 Week 96 will enter Step 3 and undergo ART cessation, as per protocol defined criteria, and remain off ART unless there is a confirmed HIV RNA rebound to ≥ LOD.  After step 3, participants who develop viral rebound or meet other Step 4 inclusion criteria will enter  Step 4 (ART re-initiation for those with confirmed viral rebound at step 3).