Status:
COMPLETED
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
Lead Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Centre for Infectious Disease Research in Zambia (CIDRZ)
Conditions:
HIV Infections
HIV Positive
Eligibility:
FEMALE
15-45 years
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.
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 th...
Eligibility Criteria
Inclusion
- 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
- History of mental illness
- History of condition that would preclude provision of consent
- Inability to provide consent
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00639145
Start Date
September 1 2010
End Date
December 1 2012
Last Update
February 8 2021
Active Locations (2)
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1
University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation
Medunsa, South Africa
2
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia