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NCT00000873 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000873
Other study ID # ACTG 247
Secondary ID PACTG 247ACTG 84
Status Completed
Phase N/A
First received November 2, 1999
Last updated October 4, 2013
Est. completion date September 2005

Study information
Verified date October 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility
Status Completed
Enrollment 2400
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 17 Days
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Infant Formula

Locations
Country Name City State
Bahamas Princess Margaret Hosp Nassau
Brazil Federal University of Minas, Dept. of Pediatrics Belo Horizonte-MG
Brazil Hosp dos Servidores do Estado Rio de Janeiro
Brazil Hosp Univ Clementino Fraga Filho Rio de Janeiro RJ
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico Caguas Regional Hosp Caguas
Puerto Rico Mayguez Med Ctr / Regional Immunology Clinic Mayguez
Puerto Rico Ponce Univ Hosp Ponce
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Children's Hosp at Albany Med Ctr Albany New York
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Med College of Georgia Augusta Georgia
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States SUNY - Brooklyn Brooklyn New York
United States Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl Camden New Jersey
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Univ of Illinois College of Medicine / Pediatrics Chicago Illinois
United States Univ of South Carolina School of Med Columbia South Carolina
United States Columbus Children's Hosp Columbus Ohio
United States The Med Ctr Inc Columbus Georgia
United States Children's Med Ctr of Dallas Dallas Texas
United States Children's Hosp of Denver Denver Colorado
United States Children's Hosp of Michigan Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr Durham North Carolina
United States Connecticut Children's Med Ctr Farmington Connecticut
United States North Broward Hosp District Fort Lauderdale Florida
United States Univ of Florida Gainesville Gainesville Florida
United States North Shore Univ Hosp Great Neck New York
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Univ of Mississippi Med Ctr Jackson Mississippi
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California
United States Long Beach Memorial (Pediatric) Long Beach California
United States Cedars Sinai / UCLA Med Ctr Los Angeles California
United States Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California
United States Los Angeles County - USC Med Ctr Los Angeles California
United States UCLA Med Ctr / Pediatric Los Angeles California
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of Miami / Jackson Memorial Hosp Miami Florida
United States Univ of South Alabama Mobile Alabama
United States St Peter's Med Ctr New Brunswick New Jersey
United States UMDNJ - Robert Wood Johnson Med School / Pediatrics New Brunswick New Jersey
United States Yale Univ Med School New Haven Connecticut
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Univ Med College New York New York
United States Harlem Hosp Ctr New York New York
United States Metropolitan Hosp Ctr New York New York
United States Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Arnold Palmer Hosp for Children & Women Orlando Florida
United States Sacred Heart Children's Hosp / CMS of Florida Pensacola Florida
United States Phoenix Childrens Hosp Phoenix Arizona
United States Med College of Virginia Richmond Virginia
United States Palm Beach County Health Dept Riviera Beach Florida
United States Univ of Rochester Med Ctr Rochester New York
United States Univ of Texas Health Sciences Ctr San Antonio Texas
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States Washington Univ School of Medicine St Louis Missouri
United States State Univ of New York at Stony Brook Stony Brook New York
United States SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York
United States Univ of South Florida Tampa Florida
United States Howard Univ Hosp Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Bahamas,  Brazil,  Puerto Rico, 

References & Publications (1)

Kaiser M, Hagopian J, Ernestine J, Moye J, Fowler M, Nesel C. Providing access to HIV-research opportunities for disenfranchised populations. Int Conf AIDS. 1998;12:845-6 (abstract no 42358)

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