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
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.
Study Type
Interventional
Primary Outcome
differences in serum lipid levels
Secondary Outcome
quantity of muscle tissue between group comparison
Condition
HIV
Intervention
testosterone injection
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
30
Start Date
September 1999
Completion Date
June 2001
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Wendy Wobeser, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00202241
Organization ID
DMED-99
Responsible Party
Principal Investigator
Study Sponsor
Queen's University
Collaborators
Ontario Ministry of Health and Long Term Care
Study Sponsor
Wendy Wobeser, MD, Principal Investigator, Queen's University
Verification Date
January 2016