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Breastfeeding, Antiretroviral, and Nutrition Study

NCT00164736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2369

Last updated 2010-04-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Charles van der Horst, MD · University of North Carolina, Chapel Hill

  • Denise J Jamieson, MD, MPH · CDC, Atlanta, GA

  • Peter Kazembe, MB ChB · Kamuzu Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Malawi

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00164736 on ClinicalTrials.gov