The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
|ClinicalTrials.gov Identifier: NCT00006064|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 29, 2014
The purpose of this study is to see how beginning or changing anti-HIV medications affects the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle distribution) of HIV-infected children. This study also looks at how changes in body composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts, height, and weight in HIV-infected children. This study also compares changes in body composition to levels of cytokines (proteins in the body that affect some immune cells) in HIV-infected children who are beginning or changing anti-HIV therapy.
Though studies have been done on adults, little is known about the effects of HIV infection and anti-HIV drugs on body composition in children. One theory is that changes in body composition can predict the failure of anti-HIV treatment. If this is true, body composition measurements can be as useful as CD4+ cell counts in determining drug effectiveness.
|Condition or disease|
|HIV Infections HIV Wasting Syndrome Lipodystrophy|
Despite accumulating data in adults, little information is available regarding the effects of HIV infection and antiretroviral therapy on body composition in children. Preliminary information indicates that lean body mass is lost in preference to fat mass in HIV-infected children, supporting the theory that failure to thrive in HIV infection is often cytokine mediated. It can be hypothesized that changes in body composition (lean body mass) may predict changes in weight growth velocity and may give an early clinical indication of treatment failure. If so, body composition measurement may yield an additional outcome measure for clinical trials, equivalent in utility to other laboratory measures of treatment response, e.g., persistent CD4+ cell count changes. Additionally, if body composition changes are highly correlated with responses in viral load, body composition may prove to be a more affordable measure of antiretroviral effectiveness in developing countries.
This study is a nonrandomized, observational study. Children are recruited to each of 4 age strata:
Stratum A: 1 month to 18 months. Stratum B: greater than 18 months to 3 years. Stratum C: greater than 3 years to 8 years. Stratum D: greater than 8 years to less than 13 years. Children beginning or changing antiretroviral therapy and fulfilling the study specifications may be enrolled in the study. Children have 5 outpatient clinic visits, at entry and at 12, 24, 36, and 48 weeks, for anthropometry, body composition by bioelectrical impedance analysis, cytokine levels, viral load, CD4+ cell count, and markers of lipid and glucose metabolism.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children|
|Study Start Date :||June 2000|
|Study Completion Date :||February 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006064
|United States, New York|
|Jacobi Med. Ctr. Bronx NICHD CRS|
|Bronx, New York, United States, 10461|
|United States, Texas|
|Texas Children's Hosp. CRS|
|Houston, Texas, United States, 77030|
|University of Puerto Rico Pediatric HIV/AIDS Research Program CRS|
|San Juan, Puerto Rico, 00935|
|Study Chair:||Caroline Chantry|
|Study Chair:||Joseph Cervia|