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.
Study Type
OBSERVATIONAL
Enrollment
3,554
Hospital General de Agudos "Jose Maria Ramos Mejia"
Buenos Aires, Argentina
Universidade de Caxias do Sul
Caxias do Sul, Brazil
Universidade Federal de Minas Gerais
Minas Gerais, Brazil
Hospital Geral Nova de Iguacu Setor De DST/AIDS
Nova Iguaçu, Brazil
Hospital Conceicao
Porto Alegre, Brazil
Hospital Femina
Porto Alegre, Brazil
Irmandade Da Santa Casa de Misericordia de
Porto Alegre, Brazil
Hospital dos Servidores do Estado - RJ
Rio de Janeiro, Brazil
Instituto de Puericultura e Pediatria
Rio de Janeiro, Brazil
Federal University of Sao Paulo-Escola Paulista de Medicina
São Paulo, Brazil
...and 2 more locations
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission
To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission.
Time frame: in utero, six weeks
To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week
To characterize adverse events according to receipt of and exposure to ARVs (by HIV- infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week
Time frame: in utero, six weeks
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