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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Infections HIV Positive Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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