A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
- Conditions
- HIV Infections
- Registration Number
- NCT00000873
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (72)
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Arnold Palmer Hosp for Children & Women
🇺🇸Orlando, Florida, United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
🇺🇸Camden, New Jersey, 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
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Caguas Regional Hosp
🇵🇷Caguas, Puerto Rico
Mayguez Med Ctr / Regional Immunology Clinic
🇵🇷Mayguez, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Univ of Miami / Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, 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
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Phoenix Childrens Hosp
🇺🇸Phoenix, Arizona, United States
Univ of South Florida
🇺🇸Tampa, Florida, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Univ of South Alabama
🇺🇸Mobile, Alabama, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, 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
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
Ponce Univ Hosp
🇵🇷Ponce, Puerto Rico
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Federal University of Minas, Dept. of Pediatrics
🇧🇷Belo Horizonte-MG, Brazil
Univ of Texas Health Sciences Ctr
🇺🇸San Antonio, Texas, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Sacred Heart Children's Hosp / CMS of Florida
🇺🇸Pensacola, Florida, United States
Connecticut Children's Med Ctr
🇺🇸Farmington, Connecticut, United States
Palm Beach County Health Dept
🇺🇸Riviera Beach, Florida, United States
The Med Ctr Inc
🇺🇸Columbus, Georgia, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Washington Univ School of Medicine
🇺🇸St Louis, Missouri, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of South Carolina School of Med
🇺🇸Columbia, South Carolina, United States
Hosp Univ Clementino Fraga Filho
🇧🇷Rio de Janeiro RJ, Brazil
Princess Margaret Hosp
🇧🇸Nassau, Bahamas
Hosp dos Servidores do Estado
🇧🇷Rio de Janeiro, Brazil