Vitamins, Breastmilk HIV Shedding, and Child Health

Completed

• Conditions: Maternal and Child Health Outcomes

• Registration Number: NCT00197756
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief Summary

The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk.

Detailed Description

The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 771

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cell-free viral load and/or cell-associated proviral load in breast milk	Delivery, 3 months, and 6 months after delivery
concentration of vitamins A, B12, and E in breast milk	Delivery, 3 months, and 6 months post-delivery
subclinical mastitis	Delivery, 3 months, and 6 months after delivery

Secondary Outcome Measures

Name	Time	Method
infant mortality and morbidity from diarrhea	Delivery, 3 months and 6 months after delivery
post-natal mother-to-child transmission of HIV	Delivery, 3 months, and 6 months post-delivery
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages	N/A (in vitro experiment)
HIV-1 replication in differentiating monocytes acutely infected with a subtype C HIV-1 clone, differentiated non-dividing MDMs acutely infected with the HIV-1 MJ4 clone, and differentiated non-dividing MDMs chronically infected with the HIV-1 MJ4 clone.	N/A (in vitro experiment)

Trial Locations

Locations (1)

Harvard School of Public Health; 🇺🇸 Boston, Massachusetts, United States