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A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants Clinical research trials and A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants. A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants clinical trial. Subjects frequently get the best healthcare possible for their A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants  A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /17 Days
Genders: Both
Protocol Entry 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.
Total Enrollment: 2400
Location and Contact Information:
Overall Study Official:
HarlandWinter, Study Chair,
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Univ of South Florida
Tampa, Florida, 33606
United States
Ponce Univ Hosp
Ponce, , 00731
Puerto Rico
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63110
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte-MG, ,
Brazil
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Mayguez Med Ctr / Regional Immunology Clinic
Mayguez, , 00680
Puerto Rico
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, 32503
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Hosp Univ Clementino Fraga Filho
Rio de Janeiro RJ, ,
Brazil
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of South Carolina School of Med
Columbia, South Carolina, 29203
United States
Caguas Regional Hosp
Caguas, , 00726
Puerto Rico
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Arnold Palmer Hosp for Children & Women
Orlando, Florida, 32806
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Hosp dos Servidores do Estado
Rio de Janeiro, ,
Brazil
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Princess Margaret Hosp
Nassau, ,
Bahamas
St Peter's Med Ctr
New Brunswick, New Jersey, 08903
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: ACTG 247; PACTG 247,ACTG 844 Substudy
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000873
Other Hiv Infections Studies:
1. Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
2. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
3. Prospective Study of HIV Infection in Hemophiliacs
4. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
5. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
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