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

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00639145

Collaborator

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

600

Enrollment

Locations

Duration (Months)

300

Patients Per Site

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections HIV Positive Pregnant Women

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.

Study Design

Study Type:

Observational

Actual Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

Number of Congenital birth defects [At birth]
Number of congenital birth defects among infants born in the study

Secondary Outcome Measures

Adverse Pregnancy outcomes [At outcome of pregnancy]
Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation	Medunsa		South Africa
2	Center for Infectious Disease Research in Zambia (CIDRZ)	Lusaka		Zambia