The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00202241
First received: September 13, 2005
Last updated: December 21, 2005
Last verified: September 2005

September 13, 2005
December 21, 2005
September 1999
Not Provided
  • differences in serum lipid levels
  • differences in regional and overall body fat level
  • impacts on metabolic and cardiovascular health
Same as current
Complete list of historical versions of study NCT00202241 on ClinicalTrials.gov Archive Site
  • quantity of muscle tissue between group comparison
  • comparison of 3 determinants of body composition(MRI,skinfold,BIA)
Same as current
Not Provided
Not Provided
 
The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS
The Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood Lipids,Muscle Mass, and Total Body Fat in People Living With HIV/AIDS

The main aim of the study is to investigate the combined effects of using anabolic steroids and protease inhibitors on fat metabolism and body composition of People Living with HIV/AIDS.

We are seeking to answer the following questions:

1) Are there any significant differences in serum blood lipids, lipodystrophy, in persons with HIV taking antiretroviral therapies and anabolic steroids versus antiretroviral therapies alone?

Changes in body composition and wasting have been a constant concern for people living with HIV/AIDS. Testosterone and its derivatives, anabolic steroids (AS) are being used by persons with HIV/AIDS (PHA's) to treat AIDs related wasting syndrome and also for bodybuilding purposes. some studies have shown that AS had a positive impact on the weight and well-being of HIV seropositive individuals.

It has been shown that protease inhibitors (PI's) in combination with other antiretroviral HIV therapies are associated with a symmetrical loss of subcutaneous fat from the body surface (lipodystrophy)in some PHAs.

The mechanism for lipodystrophy is not well understood. However, it is associated with hyperlipidemia that contributes to central fat deposition, insulin resistance, and in some, type 2 diabetes. As well, increased visceral abdominal fat and loss of fat inthe arms, legs and face, and increased levels of serum lipids have been reported.The health effects of anabolic steroid therapy coupled with PIs has not been examined before.

This study is an observational study investigating the phenomenon of lipodystrophy in an HIV population already exposed to AS and PIs. A prospective observational design will be employed, with two groups recruited. One group will be taking AS and PI's, the other will be taking PIs only.

The groups will be asked to completed Quality of Life nutrition and physical activity questionnaires. Serum blood lipid characteristics will be compared, and body composition will be determined using MRIs, BIA's and skinfold measurements.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV
  • AIDS
  • Lipodystrophy
  • Hyperlipidemia
Procedure: testosterone injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2001
Not Provided

Inclusion Criteria:

  • documented HIV seropositive status
  • 18 years of age or older
  • combination antiretroviral therapies for at least three months or more
  • able to comply with study procedures and protocol
  • signed informed consent

Exclusion Criteria:

  • acute opportunistic infections at baseline
  • use of serum lipid lowering drugs
  • use of serum sugar controlling drugs
  • evidence of drug or alcohol use which may interfere with study participation
  • a recent illness with associate weight loss of greater than or equal to 10lbs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00202241
DMED-99
Not Provided
Not Provided
Queen's University
Ontario Ministry of Health and Long Term Care
Principal Investigator: Wendy Wobeser, MD Queen's University
Queen's University
September 2005

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