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

February 3, 2021 updated by: Elizabeth Glaser Pediatric AIDS Foundation

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

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Medunsa, South Africa
        • University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation
  • Zambia
      • Lusaka, Zambia
        • Center for Infectious Disease Research in Zambia (CIDRZ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

HIV positive pregnant women attending ART clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Congenital birth defects
Time Frame: At birth
Number of congenital birth defects among infants born in the study
At birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Pregnancy outcomes
Time Frame: At outcome of pregnancy
Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight
At outcome of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

Harvard School of Public Health (HSPH)
Centre for Infectious Disease Research in Zambia (CIDRZ)
University of Limpopo MEDUNSA
Health Systems Trust (HST)

Investigators

  • Principal Investigator: Richard Marlink, MD, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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