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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639145
First Posted: March 20, 2008
Last Update Posted: August 14, 2013
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.
Collaborators:
Harvard School of Public Health
Centre for Infectious Disease Research in Zambia (CIDRZ)
University of Limpopo MEDUNSA
Health Systems Trust (HST)
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation
March 14, 2008
March 20, 2008
August 14, 2013
September 2010
December 2012   (Final data collection date for primary outcome measure)
Number of Congenital birth defects [ Time Frame: At birth ]
Same as current
Complete list of historical versions of study NCT00639145 on ClinicalTrials.gov Archive Site
Adverse Pregnancy outcomes [ Time Frame: At outcome of pregnancy ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
HIV positive pregnant women attending ART clinics
  • HIV Infections
  • HIV Positive
  • Pregnant Women
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
15 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Zambia
Côte D'Ivoire
 
NCT00639145
EGPAF-001
No
Not Provided
Not Provided
Elizabeth Glaser Pediatric AIDS Foundation
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
Elizabeth Glaser Pediatric AIDS Foundation
August 2013