NCT00639145

Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol

Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• HIV Positive
• Pregnant Women

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-03-20
• Last updated: 2021-02-08

Locations

2 sites across 2 countries: South Africa, Zambia