Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol (MEP Project)
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|ClinicalTrials.gov Identifier: NCT00639145|
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : August 14, 2013
|Condition or disease|
|HIV Infections HIV Positive Pregnant Women|
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.
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus‐Infected Women Receiving Antiretroviral Therapy in Sub‐ Saharan Africa|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- Number of Congenital birth defects [ Time Frame: At birth ]
- Adverse Pregnancy outcomes [ Time Frame: At outcome of pregnancy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|