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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| 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) |
| ClinicalTrials.gov Identifier: | NCT00069004 |
Purpose
The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Metabolism, body composition, bone density, and other factors will be assessed in relationship to participants' exposure to highly active antiretroviral therapy (HAART).
| Condition |
|---|
|
HIV Infections HIV-Associated Lipodystrophy Syndrome HIV Lipodystrophy Syndrome Lipodystrophy Dyslipidemia Osteoporosis Osteopenia |
| Study Type: | Observational |
| Official Title: | Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth |
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2003 |
Despite advances in HIV care associated with HAART, many patients on HAART regimens develop physical and metabolic problems, including changes in body fat distribution (lipodystrophy), osteopenia and osteoporosis, dyslipidemia, and hyperlactatemia. Early studies suggest that protease inhibitors (PIs) were directly responsible for HIV Lipodystrophy Syndrome (HLS) and skeletal complications in HAART-treated patients. This study will compare HIV infected, HAART-treated children and youth and their uninfected counterparts to make connections between HAART, HLS, and skeletal and metabolic problems. The study is the first to address the prevalence and risk assessment of these complications in children, and will be useful in predicting long-term prognosis in HIV patients who use or have used HAART.
There will be three groups in the study. Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention. Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen (Group 2) or a PI-containing regimen (Group 3). Screening evaluations will be conducted within 30 days prior to study entry. Study evaluations may be completed at study entry or over the course of up to 3 study visits. All participants will undergo whole body and regional DEXA scans (to assess bone density), measurements to determine sexual maturity, and blood work.
Eligibility| Ages Eligible for Study: | 7 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
For HIV uninfected participants (Group 1)
For HIV infected participants (Groups 2 and 3)
For all participants
Exclusion Criteria
Contacts and Locations
Show 45 Study Locations| Study Chair: | Grace Aldrovandi, MD | University of Alabama at Birmingham |
| Study Chair: | Peggy Borum, PhD | University of Florida |
More Information
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00069004 History of Changes |
| Other Study ID Numbers: | PACTG P1045, 10108 |
| Study First Received: | September 12, 2003 |
| Last Updated: | October 31, 2011 |
| Health Authority: | United States: Federal Government |
|
HIV-Associated Lipodystrophy Syndrome HIV Lipodystrophy Syndrome Treatment Experienced Lipodystrophy |
Dyslipidemia Osteoporosis Osteopenia |
|
Congenital Abnormalities HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy Bone Diseases, Metabolic Osteoporosis Dyslipidemias HIV-Associated Lipodystrophy Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Bone Diseases Musculoskeletal Diseases |