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: June 23, 2014
Last verified: April 2014

August 25, 2003
June 23, 2014
July 2003
June 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00067587 on ClinicalTrials.gov Archive Site
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Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

  • HIV Infections
  • Hypercholesterolemia
  • Glucose Intolerance
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2005
June 2005   (final data collection date for primary outcome measure)

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
Female
12 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067587
ATN 021
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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)
Study Chair: Grace Aldrovandi, MD Children's Hospital Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP