NCT00164736

Breastfeeding, Antiretroviral, and Nutrition Study

HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,369 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

This is a comparative clinical trial among HIV-infected women and their infants to determine: 1. the benefit of nutritional supplementation given to women during breastfeeding 2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding 3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation

Detailed description

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: 1. 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). 2. 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. 3. 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Maternal zidovudine/lamivudine/lopinavir-ritonavir	Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
DRUG	Infant nevirapine	Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg. To 28 weeks while breastfeeding.
DIETARY_SUPPLEMENT	Maternal protein and calorie supplement	High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.

Timeline

• Start date: 2004-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2005-09-14
• Last updated: 2010-04-23

Locations

1 site across 1 country: Malawi