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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)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date October 7, 2013
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: Infant Formula
Study Arms  ICMJE Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
2400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bahamas,   Brazil,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000873
Other Study ID Numbers  ICMJE ACTG 247
PACTG 247
ACTG 844 Substudy
11224 ( Registry Identifier: DAIDS ES )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Chair: Harland S Winter
Study Chair: James Oleske
Study Chair: Ross McKinney
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP