Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000873
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
1999-11-02
Brief Title:
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Controlled Study of an Increased Caloric Density Infant Formula and Its Effect on Growth and Nutritional Status in HIV-Infected Infants
Status:
COMPLETED
Status Verified Date:
2013-10
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 study examines the effects of an infant formula containing increased calories as compared to commercial formulas when given during the first 6 months of life It will examine effects on growth disease progress immune system and quality of life of infected infants
HIV disease in infants often leads to nutritional deficiencies Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers
HIV disease in infants often leads to nutritional deficiencies Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers
Detailed Description:
In order to meet the optimal nutritional needs of HIV-infected infants it is critical that nutritional intervention begin early Early nutritional intervention may help reduce the susceptibility to or severity of primary HIV andor opportunistic infections and add to the quality of life for children perinatally infected with HIV
AS PER AMENDMENT 082901 This study population will consist of infants from domestic sites and international sites In this double-blind controlled study perinatally HIV-exposed infants less than 15 days old AS PER AMENDMENT 082901 less than 15 days old has been replaced with less than 17 days old at time of study entry are randomized to 1 of 2 arms to receive either concentrated formula or standard formula for 8 weeks after being stratified by gestational age less than 37 versus greater than 37 completed weeks At the 8-week visit using a previously determined 81 random allocation 89 of singleton infants AS PER AMENDMENT 082901 from international sites with negative HIV-specific tests are discontinued from study treatment and further follow-up The other 11 percent of these singleton infants with negative HIV-specific tests continue study treatment with open-label standard formula until Week 28 control group Singleton infants with positive HIV-specific tests continue on the blinded portion of the study and receive formula as initially assigned until Week 28 For a given multiple birth if any of the infants at the 8-week study visit are determined to be infected all the infants from that birth continue their initial blinded treatment assignment until Week 28 if none of the infants are determined to be infected at this time all the infants from that birth continue study treatment with open-label standard formula until Week 28 All infants assigned to receive study treatment through Week 28 continue study follow-up until 12 months of age A subset of patients at sites with appropriate resources will participate in a substudy in which measurements of triceps and thigh skinfold thickness and circumference and thigh density DEXA scans are evaluated
AS PER AMENDMENT 082901 This study population will consist of infants from domestic sites and international sites In this double-blind controlled study perinatally HIV-exposed infants less than 15 days old AS PER AMENDMENT 082901 less than 15 days old has been replaced with less than 17 days old at time of study entry are randomized to 1 of 2 arms to receive either concentrated formula or standard formula for 8 weeks after being stratified by gestational age less than 37 versus greater than 37 completed weeks At the 8-week visit using a previously determined 81 random allocation 89 of singleton infants AS PER AMENDMENT 082901 from international sites with negative HIV-specific tests are discontinued from study treatment and further follow-up The other 11 percent of these singleton infants with negative HIV-specific tests continue study treatment with open-label standard formula until Week 28 control group Singleton infants with positive HIV-specific tests continue on the blinded portion of the study and receive formula as initially assigned until Week 28 For a given multiple birth if any of the infants at the 8-week study visit are determined to be infected all the infants from that birth continue their initial blinded treatment assignment until Week 28 if none of the infants are determined to be infected at this time all the infants from that birth continue study treatment with open-label standard formula until Week 28 All infants assigned to receive study treatment through Week 28 continue study follow-up until 12 months of age A subset of patients at sites with appropriate resources will participate in a substudy in which measurements of triceps and thigh skinfold thickness and circumference and thigh density DEXA scans are evaluated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11224 | REGISTRY | DAIDS ES | None |
| PACTG 247 | None | None | None |
| ACTG 844 Substudy | None | None | None |