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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Elizabeth Glaser Pediatric AIDS Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT00639145
First received: March 14, 2008
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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
HIV Infections
HIV Positive
Pregnant Women

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Elizabeth Glaser Pediatric AIDS Foundation:

Primary Outcome Measures:
  • Number of Congenital birth defects [ Time Frame: At birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse Pregnancy outcomes [ Time Frame: At outcome of pregnancy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 520
Study Start Date: September 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV positive pregnant women attending ART clinics

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639145

Locations
South Africa
University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation
Medunsa, South Africa
Zambia
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Investigators
Principal Investigator: Richard Marlink, MD Elizabeth Glaser Pediatric AIDS Foundation
  More Information

No publications provided

Responsible Party: Vice President Technical Implementation, Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT00639145     History of Changes
Other Study ID Numbers: EGPAF-001
Study First Received: March 14, 2008
Last Updated: June 21, 2011
Health Authority: South Africa: Research and Ethics Committee
United States: Institutional Review Board
Zambia: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013