Status:
COMPLETED
Zambia Exclusive Breastfeeding Study
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
United States Agency for International Development (USAID)
National Institutes of Health (NIH)
Conditions:
HIV Infection
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusiv...
Detailed Description
It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings, where the HIV epidemic now p...
Eligibility Criteria
Inclusion
- HIV-positive pregnant women identified through VCT
- After counseling about the risks and benefits of feeding alternatives report that it is their intended decision to breastfeed
- Live within the catchment area of George or Chawama clinic
- Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a minimum of 2 lactation counseling sessions prior to delivery)
- Do not have any significant presenting illness that requires hospitalization
- Agree to adhere to the requirements of study participation (including exclusive breastfeeding and randomization into one of two infant feeding groups at four months).
- Willing to inform a household member (preferably husband/father) of HIV-status.
Exclusion
- Lives outside of catchment area;
- Have known major illnesses likely to influence pregnancy outcome including diabetes, severe renal or heart disease, or active tuberculosis, prior to randomization;
- Does not intend to breastfeed;
- Prior enrollment in this study or concurrent enrollment in another study
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
1435 Patients enrolled
Trial Details
Trial ID
NCT00310726
Start Date
May 1 2001
End Date
December 1 2006
Last Update
July 27 2011
Active Locations (1)
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1
George and Chawama District Health Clinics
Lusaka, Zambia