Official Title: "HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health"
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary Outcome Measures
Secondary Outcome Measures
Total enrollment: 2373
Study start date: March 2004
Final randomization: February 2009
Primary completion date: September 2009 (final data collection date for primary outcome measures)
Secondary completion date: January 2010 (final data collection date for secondary outcome measures)
This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include assessment of mortality and morbidity among HIV-infected women; evaluation of interventions to reduce HIV transmission to infants exposed by breast milk; and assessment of early weaning as a risk-reduction strategy for infants of HIV-infected mothers.
The study will evaluate the following:
- The efficacy of a high-density caloric/micronutrient nutritional supplement given to HIV-infected women who breastfeed in preventing maternal depletion (weight loss and micronutrient status).
- The safety and efficacy of maternal or infant antiretroviral regimens, taken for up to 6 months during breastfeeding, in reducing infant HIV infection rates at 48 weeks.
- The feasibility of exclusive breastfeeding for 6 months followed by rapid weaning.
Additional study objectives are to evaluate the feasibility of delivering these interventions in resource poor settings and to identify maternal, infant, and virologic factors associated with HIV transmission during breastfeeding.
Ages Eligible for Study: 14 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Recruitment and primary eligibility criteria
Secondary eligibility criteria and treatment assignment