Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

The current low rate of vertical transmission of HIV in the U.S. limits the number and types
of questions concerning transmission risk and pathogenesis that can be addressed by a single
clinical trial. Specific U.S. Public Health Service guidelines recommend antiretroviral
therapy (ART) during pregnancy to maximize health of women. However, data regarding the
effectiveness and safety of and adherence to ART during pregnancy are limited. It is both
appropriate and necessary for theInternational Maternal Pediatric Adolescent AIDS Clinical
Trials Group (IMPAACT) to recruit pregnant women into a non-interventional, analytic,
epidemiologic study to methodically collect clinical and laboratory data from them and their
infants. This way, the IMPAACT can achieve the aims of evaluating management of HIV-infected
women during pregnancy and determining the safety and effectiveness of ART and other
interventions intended to prevent vertical transmission and/or improve maternal health. In
addition, longitudinally collected core protocol data and repository specimens will enable
future substudies.

Participants receive no protocol specific treatment or other intervention as part of this
study. The study involves the follow-up of HIV-infected women enrolled during pregnancy or
at the time of delivery for 6 months postpartum and their infants for the first 6 months of
life. There will be 8 study visits for enrolled participants and 6 study visits for infants.
Data concerning ART use, adherence to medications, and review of symptoms relevant to side
effects and toxicities are collected through administration of questionnaires at all
maternal visits. Phlebotomy is conducted to obtain specimens for a repository and for
required laboratory tests. During labor and delivery, maternal blood is obtained for
lymphocyte subset and viral load assays and for repository storage. Collection of amniotic
fluid at the time of cesarean section is encouraged. These collections are submitted to a
central repository. Data for the core protocol are abstracted from the infant's medical
record at the time of birth and at each postnatal visit.

Inclusion Criteria:

- HIV infected

- At least 14 weeks pregnant OR have delivered a liveborn or stillborn infant and are
within 14 days of the delivery

- Currently receiving care at an IMPAACT or other participating site

- Have a parent or guardian willing to provide signed informed consent, if applicable

- Mentally capable of giving informed consent to have the infant and self followed at
an IMPAACT site

Exclusion Criteria:

- Intend to end the pregnancy

- Unable to come for a study visit within 14 days after delivery (if known to be HIV
infected prior to delivery) OR within 28 days after delivery (if found to be HIV
infected at the time of labor and delivery or within 14 days after delivery)