A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Infant Formula
Intervention type(s): Drug
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Nutritional Status; HIV Seronegativity; Infant Food