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Completed

NCT Number: NCT00639145

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases HIV Positive HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pregnant Women RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation, Medunsa, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Congenital birth defects

    Time frame: At birth

    Number of congenital birth defects among infants born in the study

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MEPProject

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 20, 2008
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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