Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164736
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2005-09-13
Brief Title:
Breastfeeding Antiretroviral and Nutrition Study
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
HIV Infection and Breastfeeding Interventions for Maternal and Infant Health
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 caloricmicronutrient 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
The study will evaluate the following
1 The efficacy of a high-density caloricmicronutrient 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PA 04003 SIP 26-04 | OTHER_GRANT | US Centers for Disease Control and Prevention | None |
| U48CCU409660 | OTHER_GRANT | None | None |