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NCT00639145 Clinical Trial

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

HIV Infections Clinical Trial

— MEPProject  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00639145
Other study ID # EG001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2010
Est. completion date December 2012

Study information
Verified date February 2021
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
South Africa University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation Medunsa
Zambia Center for Infectious Disease Research in Zambia (CIDRZ) Lusaka

Sponsors (5)
Lead Sponsor Collaborator
Elizabeth Glaser Pediatric AIDS Foundation Centre for Infectious Disease Research in Zambia (CIDRZ), Harvard School of Public Health, Health Systems Trust (HST), University of Limpopo MEDUNSA

Countries where clinical trial is conducted

South Africa,  Zambia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Congenital birth defects Number of congenital birth defects among infants born in the study At birth
Secondary Adverse Pregnancy outcomes Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight At outcome of pregnancy
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