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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00067587 |
Though anti-HIV drugs can dramatically improve the health of people with HIV, some people taking these drugs develop serious long term effects in their metabolism. These effects include problems with bones, increased levels of blood sugar and lipids, and changes in body fat distribution. The purpose of this study is to see how many young women are experiencing these problems and how severe the problems are. This kind of study is the first step in determining how best to treat these problems.
Condition |
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HIV Infections Hypercholesterolemia Glucose Intolerance |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women |
Estimated Enrollment: | 250 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | June 2005 |
Patients on highly active antiretroviral therapy (HAART) regimens develop potentially deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and osteoporosis, and hyperlactatemia. Changes in body fat distribution and bone metabolism are also documented. There is considerable evidence that protease inhibitors (PI) can induce insulin resistance and increase triglyceride and cholesterol levels. It is now also clear that both metabolic changes and fat distribution abnormalities occur in PI-naive patients treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs). In addition to class specific effects, there is emerging evidence that there are differences within each class of drug in the nature and magnitude of metabolic effects. This study will examine the metabolic effects of HAART in young women.
Adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata: Stratum 1 - HIV uninfected; Stratum 2 - HIV infected but never had HAART; Stratum 3 - HIV infected on NNRTI regimen for 3 or more months and less than 2 weeks of PI therapy; Stratum 4 - HIV infected on PI regimen for 3 or more months and less than 2 weeks of NNRTI therapy; and Stratum 5 - HIV infected on NRTI-only regimen for 3 or more months and less than 2 weeks of PI or NNRTI therapy. Participants in the study will have one study visit conducted over 1 or 2 days. The study visit will include survey questionnaires, DEXA scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism.
Ages Eligible for Study: | 12 Years to 24 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria
Exclusion criteria
United States, California | |
University of California at San Diego | |
San Diego, California, United States | |
Children's Hopsital of Los Angeles | |
Los Angeles, California, United States | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States | |
University of South Florida | |
Tampa, Florida, United States | |
Children's Diagnostic and Treatment Center | |
Fort Lauderdale, Florida, United States | |
United States, Illinois | |
Stoger Hospital of Cook County | |
Chicago, Illinois, United States | |
United States, Louisiana | |
Tulane University | |
New Orleans, Louisiana, United States | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States | |
Mt. Sinai Hospital | |
New York City, New York, United States | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States |
Study Chair: | Grace Aldrovandi, MD | Children's Hospital Los Angeles |
Study ID Numbers: | ATN 021 |
Study First Received: | August 25, 2003 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00067587 History of Changes |
Health Authority: | United States: Federal Government |
Treatment experienced Treatment naive |
Sexually Transmitted Diseases, Viral Hyperlipidemias Metabolic Diseases Acquired Immunodeficiency Syndrome Glucose Intolerance Immunologic Deficiency Syndromes Virus Diseases Hyperglycemia HIV Infections |
Sexually Transmitted Diseases Glucose Metabolism Disorders Congenital Abnormalities Metabolic Disorder Hypercholesterolemia Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |
RNA Virus Infections Sexually Transmitted Diseases, Viral Metabolic Diseases Hyperlipidemias Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Glucose Intolerance Infection Immunologic Deficiency Syndromes |
Virus Diseases Hyperglycemia HIV Infections Sexually Transmitted Diseases Lentivirus Infections Glucose Metabolism Disorders Hypercholesterolemia Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |