Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02115


Purpose:

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.


Study 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


Criteria:

This study is analyzing samples previously collected from the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The inclusion criteria in this study was: - HIV infected women presenting to antenatal care between 12 and 27 weeks of gestation


Study is Available At:


Original ID:

HD45134


NCT ID:

NCT00197756


Secondary ID:


Study Acronym:


Brief Title:

Vitamins, Breastmilk HIV Shedding, and Child Health


Official Title:

Vitamins, Breastmilk HIV Shedding, and Child Health


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Harvard School of Public Health


Oversight Authority:

  • United States: Federal Government
  • Tanzania: Ministry of Health


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

771


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eduardo Villamor, MD,DrPH
Principal Investigator
Harvard School of Public Health

Study Dates

Start Date:September 2004
Completion Date:August 2007
Completion Type:Actual
Primary Completion Date:August 2007
Primary Completion Type:Actual
Verification Date:August 2009
Last Changed Date:August 20, 2009
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:cell-free viral load and/or cell-associated proviral load in breast milk
Time Frame:Delivery, 3 months, and 6 months after delivery
Safety Issues:True
Outcome Type:Primary Outcome
Measure:concentration of vitamins A, B12, and E in breast milk
Time Frame:Delivery, 3 months, and 6 months post-delivery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:subclinical mastitis
Time Frame:Delivery, 3 months, and 6 months after delivery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:post-natal mother-to-child transmission of HIV
Time Frame:Delivery, 3 months, and 6 months post-delivery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:infant mortality and morbidity from diarrhea
Time Frame:Delivery, 3 months and 6 months after delivery
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages
Time Frame:N/A (in vitro experiment)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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.
Time Frame:N/A (in vitro experiment)
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Vitamin A alone
Description:30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
Arm Name:Vitamin A
Intervention Type:Dietary Supplement
Name:Multivitamins excluding vitamin A
Description:30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
Arm Name:No Vitamin A
Intervention Type:Dietary Supplement
Name:multivitamins including vitamin A
Description:20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
Arm Name:No Vitamin A
Intervention Type:Other
Name:Placebo
Description:Placebo pill taken orally once per day during pregnancy and lactation
Arm Name:No Vitamin A

Study Arms

Study Arm Type:Other
Arm Name:Vitamin A
Description:Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A.
Study Arm Type:Other
Arm Name:No Vitamin A
Description:Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo.
Study Arm Type:Other
Arm Name:Multivitamins
Description:Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A
Study Arm Type:Other
Arm Name:No Multivitamins
Description:Participants from the parent study who had been randomized to vitamin A alone or placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Harvard School of Public Health
Agency Class:Other
Agency Type:Collaborator
Agency Name:Muhimbili University of Health and Allied Sciences

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Breast milk samples collected from breast at delivery and at 3 month intervals thereafter.
Study Population: The data and samples used in this study are from HIV-infected pregnant women who participated in the "Trial of Vitamins in HIV Transmission and Progression". Between 1995 and 1997, 1,078 African, HIV positive women who were between gestatopm weeks 12 and 27 were recruited. They were followed until August 2003. This study was conducte among 771 of these women, for whom breast milk samples were available at delivery. There were no differences in baseline characteristics between this subset and the originally randomized group of 1,069.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.