A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
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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 |
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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.
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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)
- HIV-1 negative (perinatally HIV-exposed but uninfected participants are eligible)
For HIV infected participants (Groups 2 and 3)
- Mother-to-child (vertically) transmitted HIV infection
- Confirmed diagnosis of HIV-1 infection by two positive assays from two different samples
- For Group 2, cannot have taken a PI-containing regimen in the 12 months prior to study entry or have ever received a PI for 2 or more weeks
- For Group 3, must currently be taking the same PI-containing regimen taken continuously for at least 12 months prior to study entry
For all participants
- Accessible medical and medications history
- Parent, legal guardian, or participant willing to give informed consent and willing to comply with study requirements
- Females who have begun menstruating must have negative pregnancy test
Exclusion Criteria
- Receipt of certain medications, including growth hormone, megestrol acetate, anabolic agents, anticytokine agents, systemic ketoconazole, systemic glucocorticoids (except if receiving stable physiologic doses), or drugs to treat osteoporosis
- Type II diabetes mellitus and unable to omit medication prior to specimen collection
- Pregnancy within the last 12 months, currently pregnant, or breastfeeding
- History of eating disorder
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Study Chair: | Grace Aldrovandi, MD | University of Alabama at Birmingham |
Study Chair: | Peggy Borum, PhD | University of Florida |
![](https://webarchive.library.unt.edu/web/20130305102526im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
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 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-Associated Lipodystrophy Syndrome HIV Lipodystrophy Syndrome Treatment Experienced Lipodystrophy |
Dyslipidemia Osteoporosis Osteopenia |
Additional relevant MeSH terms:
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 |
ClinicalTrials.gov processed this record on March 03, 2013