Breastfeeding, Antiretroviral, and Nutrition Study

PHASE3CompletedINTERVENTIONAL
Enrollment

2,369

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
HIV Infections
Interventions
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.

Trial Locations (1)

Unknown

Kamuzu Central Hospital, Bottom Hospital, Lilongwe

All Listed Sponsors
collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

Kamuzu Central Hospital

OTHER

lead

Centers for Disease Control and Prevention

FED

NCT00164736 - Breastfeeding, Antiretroviral, and Nutrition Study | Biotech Hunter | Biotech Hunter