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Trial record 39 of 3132 for:    HIV Infections | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000873
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 7, 2013
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Infant Formula Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 2400 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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
Actual Study Completion Date : September 2005

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Ages Eligible for Study:   up to 17 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000873


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Locations
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United States, Alabama
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Univ of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Connecticut Children's Med Ctr
Farmington, Connecticut, United States, 060303805
Yale Univ Med School
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
United States, Florida
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
Univ of Florida Gainesville
Gainesville, Florida, United States, 32610
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Arnold Palmer Hosp for Children & Women
Orlando, Florida, United States, 32806
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, United States, 32503
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
Univ of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Med College of Georgia
Augusta, Georgia, United States, 30912
The Med Ctr Inc
Columbus, Georgia, United States, 31901
United States, Illinois
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, Mississippi
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
United States, Missouri
Washington Univ School of Medicine
St Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, United States, 08103
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
St Peter's Med Ctr
New Brunswick, New Jersey, United States, 08903
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Cornell Univ Med College
New York, New York, United States, 10021
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Harlem Hosp Ctr
New York, New York, United States, 10037
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Ohio
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Univ of South Carolina School of Med
Columbia, South Carolina, United States, 29203
United States, Texas
Children's Med Ctr of Dallas
Dallas, Texas, United States, 75235
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 78284
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 23219
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Bahamas
Princess Margaret Hosp
Nassau, Bahamas
Brazil
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte-MG, Brazil
Hosp Univ Clementino Fraga Filho
Rio de Janeiro RJ, Brazil
Hosp dos Servidores do Estado
Rio de Janeiro, Brazil
Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956
Caguas Regional Hosp
Caguas, Puerto Rico, 00726
Mayguez Med Ctr / Regional Immunology Clinic
Mayguez, Puerto Rico, 00680
Ponce Univ Hosp
Ponce, Puerto Rico, 00731
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Chair: Harland S Winter
Study Chair: James Oleske
Study Chair: Ross McKinney

Publications:
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)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000873     History of Changes
Other Study ID Numbers: ACTG 247
PACTG 247
ACTG 844 Substudy
11224 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: October 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Nutritional Status
HIV Seronegativity
Infant Food

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases