Clinical trial NCT00000873: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Nutritional Status
HIV Seronegativity
Infant Food
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2001-08-31
Enrollment: 2400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham - Pediatric
state: Alabama
city: Mobile
country: United States
facility: Univ of South Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Childrens Hosp
state: Arizona
city: La Jolla
country: United States
facility: UCSD Med Ctr / Pediatrics / Clinical Sciences
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial (Pediatric)
state: California
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai / UCLA Med Ctr
state: California
city: Los Angeles
country: United States
facility: UCLA Med Ctr / Pediatric
state: California
city: Los Angeles
country: United States
facility: Harbor - UCLA Med Ctr / UCLA School of Medicine
state: California
city: Denver
country: United States
facility: Children's Hosp of Denver
state: Colorado
city: Farmington
country: United States
facility: Connecticut Children's Med Ctr
state: Connecticut
city: New Haven
country: United States
facility: Yale Univ Med School
state: Connecticut
city: Washington
country: United States
facility: Howard Univ Hosp
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District
state: Florida
city: Gainesville
country: United States
facility: Univ of Florida Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Univ of Florida Health Science Ctr / Pediatrics
state: Florida
city: Miami
country: United States
facility: Univ of Miami / Jackson Memorial Hosp
state: Florida
city: Miami
country: United States
facility: Univ of Miami (Pediatric)
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hosp for Children & Women
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Children's Hosp / CMS of Florida
state: Florida
city: Riviera Beach
country: United States
facility: Palm Beach County Health Dept
state: Florida
city: Tampa
country: United States
facility: Univ of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory Univ Hosp / Pediatrics
state: Georgia
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Columbus
country: United States
facility: The Med Ctr Inc
state: Georgia
city: Chicago
country: United States
facility: Univ of Illinois College of Medicine / Pediatrics
state: Illinois
city: Chicago
country: United States
facility: Chicago Children's Memorial Hosp
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ / Charity Hosp of New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Univ of Maryland at Baltimore / Univ Med Ctr
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hosp - Pediatric
state: Maryland
city: Boston
country: United States
facility: Children's Hosp of Boston
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Med Ctr of Springfield
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hosp of Michigan
state: Michigan
city: Jackson
country: United States
facility: Univ of Mississippi Med Ctr
state: Mississippi
city: St Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Camden
country: United States
facility: Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
state: New Jersey
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Med School / Pediatrics
state: New Jersey
city: New Brunswick
country: United States
facility: St Peter's Med Ctr
state: New Jersey
city: Newark
country: United States
facility: Univ of Medicine & Dentistry of New Jersey / Univ Hosp
state: New Jersey
city: Newark
country: United States
facility: Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
state: New Jersey
city: Albany
country: United States
facility: Children's Hosp at Albany Med Ctr
state: New York
city: Bronx
country: United States
facility: Bronx Lebanon Hosp Ctr
state: New York
city: Brooklyn
country: United States
facility: SUNY - Brooklyn
state: New York
city: Great Neck
country: United States
facility: North Shore Univ Hosp
state: New York
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Cornell Univ Med College
state: New York
city: New York
country: United States
facility: Metropolitan Hosp Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: New York
country: United States
facility: Harlem Hosp Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Stony Brook
country: United States
facility: State Univ of New York at Stony Brook
state: New York
city: Syracuse
country: United States
facility: SUNY Health Sciences Ctr at Syracuse / Pediatrics
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Durham
country: United States
facility: Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
state: North Carolina
city: Columbus
country: United States
facility: Columbus Children's Hosp
state: Ohio
city: Charleston
country: United States
facility: Med Univ of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Univ of South Carolina School of Med
state: South Carolina
city: Dallas
country: United States
facility: Children's Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hosp / Baylor Univ
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Sciences Ctr
state: Texas
city: Richmond
country: United States
facility: Med College of Virginia
state: Virginia
city: Seattle
country: United States
facility: Children's Hospital & Medical Center / Seattle ACTU
state: Washington
city: Nassau
country: Bahamas
facility: Princess Margaret Hosp
city: Belo Horizonte-MG
country: Brazil
facility: Federal University of Minas, Dept. of Pediatrics
city: Rio de Janeiro RJ
country: Brazil
facility: Hosp Univ Clementino Fraga Filho
city: Rio de Janeiro
country: Brazil
facility: Hosp dos Servidores do Estado
city: Bayamon
country: Puerto Rico
facility: Ramon Ruiz Arnau Univ Hosp / Pediatrics
city: Caguas
country: Puerto Rico
facility: Caguas Regional Hosp
city: Mayguez
country: Puerto Rico
facility: Mayguez Med Ctr / Regional Immunology Clinic
city: Ponce
country: Puerto Rico
facility: Ponce Univ Hosp
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico / Univ Children's Hosp AIDS
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp
Study officials:
name: Harland S Winter
role: STUDY_CHAIR
name: James Oleske
role: STUDY_CHAIR
name: Ross McKinney
role: STUDY_CHAIR
References:
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)