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.

Condition	Treatment or Intervention
HIV Infections	Drug: Infant Formula

Further Study Details: 

Expected Total Enrollment:  2400

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.

Ages Eligible for Study:  up to  17 Days,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Alabama
      Univ of South Alabama, Mobile,  Alabama,  36604,  United States
      Univ of Alabama at Birmingham - Pediatric, Birmingham,  Alabama,  35233,  United States
Arizona
      Phoenix Childrens Hosp, Phoenix,  Arizona,  85006,  United States
California
      UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla,  California,  920930672,  United States
      Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles,  California,  905022004,  United States
      UCLA Med Ctr / Pediatric, Los Angeles,  California,  900951752,  United States
      Cedars Sinai / UCLA Med Ctr, Los Angeles,  California,  900481804,  United States
      Long Beach Memorial (Pediatric), Long Beach,  California,  90801,  United States
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
Colorado
      Children's Hosp of Denver, Denver,  Colorado,  802181088,  United States
Connecticut
      Yale Univ Med School, New Haven,  Connecticut,  06504,  United States
      Connecticut Children's Med Ctr, Farmington,  Connecticut,  060303805,  United States
District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States
Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States
      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States
      Univ of South Florida, Tampa,  Florida,  33606,  United States
      Arnold Palmer Hosp for Children & Women, Orlando,  Florida,  32806,  United States
      North Broward Hosp District, Fort Lauderdale,  Florida,  33311,  United States
      Univ of Florida Gainesville, Gainesville,  Florida,  32610,  United States
      Palm Beach County Health Dept, Riviera Beach,  Florida,  33404,  United States
      Univ of Miami / Jackson Memorial Hosp, Miami,  Florida,  33136,  United States
      Sacred Heart Children's Hosp / CMS of Florida, Pensacola,  Florida,  32503,  United States
Georgia
      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
Illinois
      Chicago Children's Memorial Hosp, Chicago,  Illinois,  606143394,  United States
      Univ of Illinois College of Medicine / Pediatrics, Chicago,  Illinois,  60612,  United States
Louisiana
      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States
Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States
      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  212874933,  United States
Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States
      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States
Michigan
      Children's Hosp of Michigan, Detroit,  Michigan,  48201,  United States
Mississippi
      Univ of Mississippi Med Ctr, Jackson,  Mississippi,  39213,  United States
Missouri
      Washington Univ School of Medicine, St. Louis,  Missouri,  63110,  United States
New Jersey
      Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark,  New Jersey,  071032714,  United States
      UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick,  New Jersey,  089030019,  United States
      Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark,  New Jersey,  07103,  United States
      Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl, Camden,  New Jersey,  08103,  United States
      St Peter's Med Ctr, New Brunswick,  New Jersey,  08903,  United States
New York
      Harlem Hosp Ctr, New York,  New York,  10037,  United States
      SUNY - Brooklyn, Brooklyn,  New York,  11203,  United States
      Cornell Univ Med College, New York,  New York,  10021,  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
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      Metropolitan Hosp Ctr, New York,  New York,  10029,  United States
      Children's Hosp at Albany Med Ctr, Albany,  New York,  12208,  United States
      SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse,  New York,  13210,  United States
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10457,  United States
      State Univ of New York at Stony Brook, Stony Brook,  New York,  117948111,  United States
      Univ of Rochester Med Ctr, Rochester,  New York,  146420001,  United States
North Carolina
      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
Ohio
      Columbus Children's Hosp, Columbus,  Ohio,  432052696,  United States
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States
      Univ of South Carolina School of Med, Columbia,  South Carolina,  29203,  United States
Texas
      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
Virginia
      Med College of Virginia, Richmond,  Virginia,  23219,  United States
Washington
      Children's Hospital & Medical Center / Seattle ACTU, Seattle,  Washington,  981050371,  United States
Bahamas
      Princess Margaret Hosp, Nassau,  Bahamas
Brazil
      Hosp Univ Clementino Fraga Filho, Rio de Janeiro - RJ,  Brazil
      Federal University of Minas, Dept. of Pediatrics, Belo Horizonte MG,  Brazil
      Hosp dos Servidores do Estado, Rio de Janeiro,  Brazil
Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico
      Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan,  009365067,  Puerto Rico
      Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon,  00956,  Puerto Rico
      Mayguez Med Ctr / Regional Immunology Clinic, Mayguez,  00680,  Puerto Rico
      Ponce Univ Hosp, Ponce,  00731,  Puerto Rico
      Caguas Regional Hosp, Caguas,  00726,  Puerto Rico

Study chairs or principal investigators

Harland S Winter,  Study Chair
James Oleske,  Study Chair
Ross McKinney,  Study Chair

Study ID Numbers:  ACTG 247; PACTG 247; ACTG 844 Substudy
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000873
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08