HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
Overview
- Phase
- Phase 3
- Intervention
- Maternal zidovudine/lamivudine/lopinavir-ritonavir
- Conditions
- HIV Infections
- Sponsor
- Centers for Disease Control and Prevention
- Enrollment
- 2369
- Locations
- 1
- Primary Endpoint
- Postpartum weight loss between delivery and 28 weeks
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
This is a comparative clinical trial among HIV-infected women and their infants to determine:
- the benefit of nutritional supplementation given to women during breastfeeding
- the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Recruitment and primary eligibility criteria:
- •Age \> 14 years.
- •Ability to give informed assent or consent.
- •Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
- •Currently pregnant (with a single or multiple fetuses).
- •Gestation \< 30 weeks at referral from 'Call to Action' Program
- •No serious current complications of pregnancy.
- •Intention to breastfeed.
- •Intention to deliver at the institution at which the study is based.
- •Not previously enrolled in this study for an earlier pregnancy.
Exclusion Criteria
- Not provided
Arms & Interventions
Maternal ARVs & Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) \& daily nutritional supplement given to the mother
Intervention: Maternal zidovudine/lamivudine/lopinavir-ritonavir
Maternal ARVs & Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) \& daily nutritional supplement given to the mother
Intervention: Maternal protein and calorie supplement
Infant NVP & Nutrition Supplement
Extended infant nevirapine for prophylaxis \& daily nutritional supplment given to the mother
Intervention: Infant nevirapine
Infant NVP & Nutrition Supplement
Extended infant nevirapine for prophylaxis \& daily nutritional supplment given to the mother
Intervention: Maternal protein and calorie supplement
Maternal ARVs & No Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) \& no nutritional supplement given to the mother
Intervention: Maternal zidovudine/lamivudine/lopinavir-ritonavir
Infant NVP & No Nutrition Supplement
Extended infant nevirapine for prophylaxis \& no nutritional supplment given to the mother
Intervention: Infant nevirapine
No Drugs & Nutrition Supplement
No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis \& daily nutritional supplement given to the mother. Note: As of March 2008, the third arm of the antiretroviral intervention, in which neither mother nor infant received drugs beyond enhanced standard of care, was stopped based on recommendations of a Data and Safety Monitoring Board review of interim efficacy results and safety data after 77% participants had received treatment assignment.
Intervention: Maternal protein and calorie supplement
Outcomes
Primary Outcomes
Postpartum weight loss between delivery and 28 weeks
Time Frame: between delivery and 28 weeks
Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.)
Time Frame: birth to 28 weeks
Exclusive breastfeeding and breastfeeding cessation by 28 weeks
Time Frame: birth to 28 weeks
Secondary Outcomes
- Duration of exclusive breastfeeding(birth to 28 weeks)
- Infant HIV status through 48 weeks(birth to 48 weeks)
- Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks(delivery to 48 weeks)