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

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: HIV Positive; Pregnant Women; HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT00639145

EG001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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