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NCT00000873

A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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 and/or opportunistic infections and add to the quality of life for children perinatally infected with HIV.

\[AS PER AMENDMENT 08/29/01: This study population will consist of infants from domestic sites and international sites.\] In this double-blind, controlled study perinatally HIV-exposed infants less than 15 days old \[AS PER AMENDMENT 08/29/01: "less than 15 days old" has been replaced with: less than 17 days old\] 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 8:1 random allocation, 89% of singleton infants \[AS PER AMENDMENT 08/29/01: from international sites\] 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.

Conditions

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HIV Infections

Keywords

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Nutritional Status HIV Seronegativity Infant Food

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Infant Formula

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Children may be eligible for this study if they:

* Are 1 to 17 days old. (This study has been changed. Originally, infants 1 to 15 days old were eligible for this study.)
* Weigh 4 or more pounds.
* Were born to an HIV-positive mother.
* Have a caregiver willing to measure and keep records of infant's food intake.

Exclusion Criteria

Children will not be eligible for this study if they:

* Are breast-fed.
* Have certain disorders, including the inability to feed by mouth, or a life-threatening condition.
* Take medication which affects growth.

Minimum Eligible Age

1 Day

Maximum Eligible Age

17 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harland S Winter

Role: STUDY_CHAIR

James Oleske

Role: STUDY_CHAIR

Ross McKinney

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, United States

Site Status

Univ of South Alabama

Mobile, Alabama, United States

Site Status

Phoenix Childrens Hosp

Phoenix, Arizona, United States

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UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States

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Long Beach Memorial (Pediatric)

Long Beach, California, United States

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

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Cedars Sinai / UCLA Med Ctr

Los Angeles, California, United States

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UCLA Med Ctr / Pediatric

Los Angeles, California, United States

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Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, United States

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Children's Hosp of Denver

Denver, Colorado, United States

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Connecticut Children's Med Ctr

Farmington, Connecticut, United States

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Yale Univ Med School

New Haven, Connecticut, United States

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Howard Univ Hosp

Washington D.C., District of Columbia, United States

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North Broward Hosp District

Fort Lauderdale, Florida, United States

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Univ of Florida Gainesville

Gainesville, Florida, United States

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Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States

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Univ of Miami / Jackson Memorial Hosp

Miami, Florida, United States

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Univ of Miami (Pediatric)

Miami, Florida, United States

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Arnold Palmer Hosp for Children & Women

Orlando, Florida, United States

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Sacred Heart Children's Hosp / CMS of Florida

Pensacola, Florida, United States

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Palm Beach County Health Dept

Riviera Beach, Florida, United States

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Univ of South Florida

Tampa, Florida, United States

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Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States

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Med College of Georgia

Augusta, Georgia, United States

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The Med Ctr Inc

Columbus, Georgia, United States

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Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, United States

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Chicago Children's Memorial Hosp

Chicago, Illinois, United States

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Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, United States

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Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, United States

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Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, United States

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Children's Hosp of Boston

Boston, Massachusetts, United States

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Baystate Med Ctr of Springfield

Springfield, Massachusetts, United States

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Children's Hosp of Michigan

Detroit, Michigan, United States

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Univ of Mississippi Med Ctr

Jackson, Mississippi, United States

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Washington Univ School of Medicine

St Louis, Missouri, United States

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Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl

Camden, New Jersey, United States

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UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, United States

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St Peter's Med Ctr

New Brunswick, New Jersey, United States

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Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, United States

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Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

Newark, New Jersey, United States

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Children's Hosp at Albany Med Ctr

Albany, New York, United States

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SUNY - Brooklyn

Brooklyn, New York, United States

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