Pregnant HIV Positive Women Clinical Trial
Official title:
A Prospective, Observational Study of HIV-Infected Pregnant Women and HIV-Exposed, Uninfected Children at Clinical Sites in Latin American Countries
By the end of 1999, it was estimated that 1.2 million children were living with HIV
infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in
less-developed countries. Most HIV-infected children are infected by transmission from mother
to child during pregnancy, at birth, or through breast milk. Antiretroviral medications,
cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to
reduce the risk of transmission. This study will determine mother-to-child transmission rates
and the effects on infants of exposure to antiretroviral medications and mode of delivery.
Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled
during the first year of this 5-year study. HIV-infected women will be evaluated during
pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be
taken and physical examination given; blood will be collected for laboratory tests.
HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history
will be taken and physical examination given; blood will be collected for laboratory tests;
and growth will be assessed.
This is an observational, prospective cohort study to describe the characteristics of HIV-infected pregnant women and HIV-exposed, uninfected children at participating clinical sites in Latin America where the following are available: 1) antiretrovirals (ARVs) for treatment of HIV-infected women and for prevention of mother-to-child transmission (MTCT) of HIV; and 2) infant formula. We will describe the utilization of interventions related to decreasing the risk of MTCT, including ARV prophylaxis, cesarean section before labor and before ruptured membranes, and complete avoidance of breastfeeding. We will describe receipt of maternal ARV regimens and determine rates of MTCT of HIV. This study will describe maternal adverse events during pregnancy and the postpartum period. In addition, the study will describe child outcomes potentially related to in utero and early postnatal exposure to ARVs. HIV-infected women will be evaluated antepartum, intrapartum, 6 months postpartum and then every 6 months for up to 5 years after delivery. HIV-exposed, uninfected children will be evaluated for up to 5 years of follow-up. ;