Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus‐Infected Women Receiving Antiretroviral Therapy in Sub‐ Saharan Africa|
- Number of Congenital birth defects [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
- Adverse Pregnancy outcomes [ Time Frame: At outcome of pregnancy ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.
The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639145
|University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation|
|Medunsa, South Africa|
|Center for Infectious Disease Research in Zambia (CIDRZ)|
|Principal Investigator:||Richard Marlink, MD||Elizabeth Glaser Pediatric AIDS Foundation|