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

October 4, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahamas
      • Nassau, Bahamas
        • Princess Margaret Hosp
  • Brazil
      • Belo Horizonte-MG, Brazil
        • Federal University of Minas, Dept. of Pediatrics
      • Rio de Janeiro, Brazil
        • Hosp dos Servidores do Estado
      • Rio de Janeiro RJ, Brazil
        • Hosp Univ Clementino Fraga Filho
  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Ramon Ruiz Arnau Univ Hosp / Pediatrics
      • Caguas, Puerto Rico, 00726
        • Caguas Regional Hosp
      • Mayguez, Puerto Rico, 00680
        • Mayguez Med Ctr / Regional Immunology Clinic
      • Ponce, Puerto Rico, 00731
        • Ponce Univ Hosp
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Univ of Alabama at Birmingham - Pediatric
      • Mobile, Alabama, United States, 36604
        • Univ of South Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Childrens Hosp
    • California
      • La Jolla, California, United States, 920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach, California, United States, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 900481804
        • Cedars Sinai / UCLA Med Ctr
      • Los Angeles, California, United States, 905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Los Angeles, California, United States, 900951752
        • UCLA Med Ctr / Pediatric
    • Colorado
      • Denver, Colorado, United States, 802181088
        • Children's Hosp of Denver
    • Connecticut
      • Farmington, Connecticut, United States, 060303805
        • Connecticut Children's Med Ctr
      • New Haven, Connecticut, United States, 06504
        • Yale Univ Med School
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard Univ Hosp
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District
      • Gainesville, Florida, United States, 32610
        • Univ of Florida Gainesville
      • Jacksonville, Florida, United States, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, United States, 33161
        • Univ of Miami (Pediatric)
      • Miami, Florida, United States, 33136
        • Univ of Miami / Jackson Memorial Hosp
      • Orlando, Florida, United States, 32806
        • Arnold Palmer Hosp for Children & Women
      • Pensacola, Florida, United States, 32503
        • Sacred Heart Children's Hosp / CMS of Florida
      • Riviera Beach, Florida, United States, 33404
        • Palm Beach County Health Dept
      • Tampa, Florida, United States, 33606
        • Univ of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ Hosp / Pediatrics
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
      • Columbus, Georgia, United States, 31901
        • The Med Ctr Inc
    • Illinois
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois College of Medicine / Pediatrics
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
      • Baltimore, Maryland, United States, 212874933
        • Johns Hopkins Hosp - Pediatric
    • Massachusetts
      • Boston, Massachusetts, United States, 021155724
        • Children's Hosp of Boston
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hosp of Michigan
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • Univ of Mississippi Med Ctr
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington Univ School of Medicine
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
      • New Brunswick, New Jersey, United States, 089030019
        • UMDNJ - Robert Wood Johnson Med School / Pediatrics
      • New Brunswick, New Jersey, United States, 08903
        • St Peter's Med Ctr
      • Newark, New Jersey, United States, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
      • Newark, New Jersey, United States, 07103
        • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
    • New York
      • Albany, New York, United States, 12208
        • Children's Hosp at Albany Med Ctr
      • Bronx, New York, United States, 10457
        • Bronx Lebanon Hosp Ctr
      • Brooklyn, New York, United States, 11203
        • SUNY - Brooklyn
      • Great Neck, New York, United States, 11021
        • North Shore Univ Hosp
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10029
        • Metropolitan Hosp Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med College
      • New York, New York, United States, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Ctr
      • Rochester, New York, United States, 146420001
        • Univ of Rochester Med Ctr
      • Stony Brook, New York, United States, 117948111
        • State Univ of New York at Stony Brook
      • Syracuse, New York, United States, 13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • Duke Univ Med Ctr
      • Durham, North Carolina, United States, 27710
        • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
    • Ohio
      • Columbus, Ohio, United States, 432052696
        • Columbus Children's Hosp
    • South Carolina
      • Charleston, South Carolina, United States, 294253312
        • Med Univ of South Carolina
      • Columbia, South Carolina, United States, 29203
        • Univ of South Carolina School of Med
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp / Baylor Univ
      • San Antonio, Texas, United States, 78284
        • Univ of Texas Health Sciences Ctr
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Med College of Virginia
    • Washington
      • Seattle, Washington, United States, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Study Chair: James Oleske
  • Study Chair: Harland S Winter
  • Study Chair: Ross McKinney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 247
  • 11224 (Registry Identifier: DAIDS ES)
  • PACTG 247
  • ACTG 844 Substudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Infant Formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe