Metabolic Abnormalities in HIV Infected and Uninfected Young Women

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00067587
First received: August 25, 2003
Last updated: October 8, 2013
Last verified: August 2013
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Resource links provided by NLM:


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

Enrollment: 300
Study Start Date: July 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV Negative
HIV negative subjects
HIV Positive - NEVER had ARV therapy.
HIV Positive - NEVER had ARV therapy.
HIV positive, on a NNRTI, non-PI regimen
HIV positive, currently on a NNRTI, non-PI regimen for at least 3 months. Must NEVER have received a total of more than SIX months of PI-containing regimen and at least ONE year must have passed since receipt of last PI-containing regimen.
HIV positive, on a PI, non-NNRTI regimen
HIV positive, currently on a PI, non-NNRTI regimen for at least 3 months. Must NEVER have received a total of more than SIX months of NNRTI-containing regimen and at least ONE year must have passed since receipt of last NNRTIcontaining regimen.
HIV positive, on a non-PI, non-NNRTI
HIV positive, currently on a non-PI, non-NNRTI containing regimen for at least 3 months. Must NEVER have received a total of more than SIX months of PI- and/or NNRTI- containing regimen and at least ONE year must have passed since receipt of last PI- and/or NNRTI-containing regimen.

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
Sampling Method:   Non-Probability Sample
Study Population

A total of up to 300 subjects may be enrolled in the study. The number of subjects in each study group will be as follow: 50 HIV negative subjects; 100 HIV positive subjects with no exposure to ART; and three groups of up to 50 HIV positive subjects each with different ART exposure histories.

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
Children's Hopsital of Los Angeles
Los Angeles, California, United States, 90027
University of California at San Diego
San Diego, California, United States, 92093
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami
Miami, Florida, United States, 33124
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stoger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mt. Sinai Hospital
New York City, New York, United States, 10128
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Grace Aldrovandi, MD Children's Hospital Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00067587     History of Changes
Other Study ID Numbers: ATN 021
Study First Received: August 25, 2003
Last Updated: October 8, 2013
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

Additional relevant MeSH terms:
Congenital Abnormalities
HIV Infections
Acquired Immunodeficiency Syndrome
Hypercholesterolemia
Glucose Intolerance
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
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on April 15, 2014