The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS
Primary Purpose
HIV, AIDS, Lipodystrophy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
testosterone injection
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV focused on measuring HIV, AIDS, testosterone, anabolic steroid, body composition, lipodystrophy, MRI, BIA, skinfold measurements, protease inhibitors
Eligibility Criteria
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
Sites / Locations
- Queen's University
Outcomes
Primary Outcome Measures
differences in serum lipid levels
differences in regional and overall body fat level
impacts on metabolic and cardiovascular health
Secondary Outcome Measures
quantity of muscle tissue between group comparison
comparison of 3 determinants of body composition(MRI,skinfold,BIA)
Full Information
NCT ID
NCT00202241
First Posted
September 13, 2005
Last Updated
January 12, 2016
Sponsor
Queen's University
Collaborators
Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT00202241
Brief Title
The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS
Official Title
The Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood Lipids,Muscle Mass, and Total Body Fat in People Living With HIV/AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Ontario Ministry of Health and Long Term Care
4. Oversight
5. Study Description
Brief Summary
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?
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, Lipodystrophy, Hyperlipidemia
Keywords
HIV, AIDS, testosterone, anabolic steroid, body composition, lipodystrophy, MRI, BIA, skinfold measurements, protease inhibitors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
testosterone injection
Primary Outcome Measure Information:
Title
differences in serum lipid levels
Title
differences in regional and overall body fat level
Title
impacts on metabolic and cardiovascular health
Secondary Outcome Measure Information:
Title
quantity of muscle tissue between group comparison
Title
comparison of 3 determinants of body composition(MRI,skinfold,BIA)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Wobeser, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS
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