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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000873

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2400

Expected to finish

2005-09-01

Last updated by the study team

2013-10-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Univ of South Alabama — Mobile, Alabama, United States
• Phoenix Childrens Hosp — Phoenix, Arizona, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Cedars Sinai / UCLA Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Connecticut Children's Med Ctr — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Univ of Florida Gainesville — Gainesville, Florida, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami / Jackson Memorial Hosp — Miami, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Arnold Palmer Hosp for Children & Women — Orlando, Florida, United States
• Sacred Heart Children's Hosp / CMS of Florida — Pensacola, Florida, United States
• Palm Beach County Health Dept — Riviera Beach, Florida, United States
• Univ of South Florida — Tampa, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• The Med Ctr Inc — Columbus, Georgia, United States
• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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