A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
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
4 other identifiers
interventional
2,400
4 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedOctober 7, 2013
October 1, 2013
November 2, 1999
October 4, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Univ of South Alabama
Mobile, Alabama, 36604, United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805, United States
Yale Univ Med School
New Haven, Connecticut, 06504, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33311, United States
Univ of Florida Gainesville
Gainesville, Florida, 32610, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Arnold Palmer Hosp for Children & Women
Orlando, Florida, 32806, United States
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, 32503, United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404, United States
Univ of South Florida
Tampa, Florida, 33606, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
The Med Ctr Inc
Columbus, Georgia, 31901, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213, United States
Washington Univ School of Medicine
St Louis, Missouri, 63110, United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019, United States
St Peter's Med Ctr
New Brunswick, New Jersey, 08903, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103, United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208, United States
SUNY - Brooklyn
Brooklyn, New York, 11203, United States
North Shore Univ Hosp
Great Neck, New York, 11021, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med College
New York, New York, 10021, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Columbus Children's Hosp
Columbus, Ohio, 432052696, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Univ of South Carolina School of Med
Columbia, South Carolina, 29203, United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284, United States
Med College of Virginia
Richmond, Virginia, 23219, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371, United States
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, Brazil
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956, Puerto Rico
Caguas Regional Hosp
Caguas, 00726, Puerto Rico
Mayguez Med Ctr / Regional Immunology Clinic
Mayguez, 00680, Puerto Rico
Ponce Univ Hosp
Ponce, 00731, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Princess Margaret Hosp
Nassau, The Bahamas
Related 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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harland S Winter
- STUDY CHAIR
James Oleske
- STUDY CHAIR
Ross McKinney
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
September 1, 2005
Last Updated
October 7, 2013
Record last verified: 2013-10