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Metabolic Abnormalities in HIV Infected and Uninfected Young Women
This study has been completed.
First Received: August 25, 2003   Last Updated: January 14, 2009   History of Changes
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)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00067587
  Purpose

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
HIV Infections
Hypercholesterolemia
Glucose Intolerance

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: AIDS Cholesterol
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 250
Study Start Date: July 2003
Estimated Study Completion Date: June 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Negative serum or urine pregnancy test if not sterilized
  • Tanner Stage 4 or 5
  • Accessible medical and medication history
  • Willing to fast and complete clinical and laboratory evaluations
  • Willingness and ability to give consent or assent with parental permission

Exclusion criteria

  • Refusal to fast for 8 hours prior to specimen collection
  • Unable to obtain history
  • Pregnancy in last 12 months or currently pregnant
  • History of anorexia or bulimia
  • Type I Diabetes mellitus
  • Type II Diabetes mellitus and cannot omit medication for the 48 hour period prior to laboratory specimen collection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067587

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Grace Aldrovandi, MD Children's Hospital Los Angeles
  More Information

Additional Information:
No publications provided

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

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Treatment experienced
Treatment naive

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009