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

Completed

• Conditions: HIV Positive; Pregnant Women; HIV Infections

• Registration Number: NCT00639145
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Study Start: 2010-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• HIV positive pregnant woman on antiretroviral treatment
• Able and willing to participate and provide informed consent
• Be at least 18 years of age or older than legal age to provide consent
• If under legal age, must have legal guardian who is able to give consent
• Be an emancipated minor

Exclusion Criteria

• History of mental illness
• History of condition that would preclude provision of consent
• Inability to provide consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Congenital birth defects	At birth	Number of congenital birth defects among infants born in the study

Secondary Outcome Measures

Name	Time	Method
Adverse Pregnancy outcomes	At outcome of pregnancy	Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight

Trial Locations

Locations (2)

Center for Infectious Disease Research in Zambia (CIDRZ); 🇿🇲 Lusaka, Zambia

University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation; 🇿🇦 Medunsa, South Africa