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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Infant Formula
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Nutritional Status, HIV Seronegativity, Infant Food

Eligibility Criteria

1 Day - 17 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham - Pediatric
  • Univ of South Alabama
  • Phoenix Childrens Hosp
  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Long Beach Memorial (Pediatric)
  • Los Angeles County - USC Med Ctr
  • Cedars Sinai / UCLA Med Ctr
  • UCLA Med Ctr / Pediatric
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • Children's Hosp of Denver
  • Connecticut Children's Med Ctr
  • Yale Univ Med School
  • Howard Univ Hosp
  • North Broward Hosp District
  • Univ of Florida Gainesville
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami / Jackson Memorial Hosp
  • Univ of Miami (Pediatric)
  • Arnold Palmer Hosp for Children & Women
  • Sacred Heart Children's Hosp / CMS of Florida
  • Palm Beach County Health Dept
  • Univ of South Florida
  • Emory Univ Hosp / Pediatrics
  • Med College of Georgia
  • The Med Ctr Inc
  • Univ of Illinois College of Medicine / Pediatrics
  • Chicago Children's Memorial Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Univ of Maryland at Baltimore / Univ Med Ctr
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Baystate Med Ctr of Springfield
  • Children's Hosp of Michigan
  • Univ of Mississippi Med Ctr
  • Washington Univ School of Medicine
  • Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
  • UMDNJ - Robert Wood Johnson Med School / Pediatrics
  • St Peter's Med Ctr
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
  • Children's Hosp at Albany Med Ctr
  • Bronx Lebanon Hosp Ctr
  • SUNY - Brooklyn
  • North Shore Univ Hosp
  • Bellevue Hosp / New York Univ Med Ctr
  • Cornell Univ Med College
  • Metropolitan Hosp Ctr
  • Columbia Presbyterian Med Ctr
  • Harlem Hosp Ctr
  • Univ of Rochester Med Ctr
  • State Univ of New York at Stony Brook
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Duke Univ Med Ctr
  • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
  • Columbus Children's Hosp
  • Med Univ of South Carolina
  • Univ of South Carolina School of Med
  • Children's Med Ctr of Dallas
  • Texas Children's Hosp / Baylor Univ
  • Univ of Texas Health Sciences Ctr
  • Med College of Virginia
  • Children's Hospital & Medical Center / Seattle ACTU
  • Princess Margaret Hosp
  • Federal University of Minas, Dept. of Pediatrics
  • Hosp Univ Clementino Fraga Filho
  • Hosp dos Servidores do Estado
  • Ramon Ruiz Arnau Univ Hosp / Pediatrics
  • Caguas Regional Hosp
  • Mayguez Med Ctr / Regional Immunology Clinic
  • Ponce Univ Hosp
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 4, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00000873
Brief Title
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Nutritional Status, HIV Seronegativity, Infant Food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
2400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Infant Formula

10. Eligibility

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

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background

Learn more about this trial

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

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