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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006064 |
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 |
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HIV Infections HIV Wasting Syndrome Lipodystrophy |
Study Type: | Observational |
Official Title: | Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children |
Estimated Enrollment: | 100 |
Study Start Date: | June 2000 |
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.
Ages Eligible for Study: | 1 Month to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
Study Chair: | Caroline Chantry | |
Study Chair: | Joseph Cervia |
Study ID Numbers: | ACTG P1010, PACTG P1010 |
Study First Received: | June 16, 2000 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00006064 History of Changes |
Health Authority: | United States: Federal Government |
Tumor Necrosis Factor CD4 Lymphocyte Count Polymerase Chain Reaction Enzyme-Linked Immunosorbent Assay RNA, Messenger Interleukin-1 |
Body Composition Anti-HIV Agents Viral Load Age Factors Anthropometry |
Sexually Transmitted Diseases, Viral Anti-HIV Agents Metabolic Diseases Skin Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Necrosis |
HIV Infections Lipodystrophy Sexually Transmitted Diseases Nutrition Disorders Wasting Syndrome Metabolic Disorder Retroviridae Infections Lipid Metabolism Disorders |
RNA Virus Infections Sexually Transmitted Diseases, Viral Disease Metabolic Diseases Slow Virus Diseases Skin Diseases Immune System Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes Virus Diseases |
Pathologic Processes Skin Diseases, Metabolic HIV Infections Syndrome Lipodystrophy Sexually Transmitted Diseases Lentivirus Infections Nutrition Disorders Wasting Syndrome Retroviridae Infections Lipid Metabolism Disorders |