An interventional study of Infant Formula in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 72 sites in 4 countries. Open to participants aged 1 Day to 17 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-07.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 2,400 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID) →