Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Number of Congenital birth defects
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Number of Congenital birth defects
Time Frame: At birth
Number of congenital birth defects among infants born in the study
Secondary Outcomes
- Adverse Pregnancy outcomes(At outcome of pregnancy)