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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00639145
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : August 14, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infections HIV Positive Pregnant Women

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 Design

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Number of Congenital birth defects [ Time Frame: At birth ]

Secondary Outcome Measures :
  1. Adverse Pregnancy outcomes [ Time Frame: At outcome of pregnancy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV positive pregnant women attending ART clinics

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
Contacts and Locations

Information from the National Library of Medicine

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

South Africa
University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation
Medunsa, South Africa
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Harvard School of Public Health
Centre for Infectious Disease Research in Zambia (CIDRZ)
University of Limpopo MEDUNSA
Health Systems Trust (HST)
Principal Investigator: Richard Marlink, MD Elizabeth Glaser Pediatric AIDS Foundation
More Information

Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT00639145     History of Changes
Other Study ID Numbers: EGPAF-001
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
HIV Seronegativity
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases