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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202241
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 13, 2016
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Dr. Wendy Wobeser, Queen's University

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?

Condition or disease Intervention/treatment Phase
HIV AIDS Lipodystrophy Hyperlipidemia Procedure: testosterone injection Not Applicable

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  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 1999
Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. differences in serum lipid levels
  2. differences in regional and overall body fat level
  3. impacts on metabolic and cardiovascular health

Secondary Outcome Measures :
  1. quantity of muscle tissue between group comparison
  2. comparison of 3 determinants of body composition(MRI,skinfold,BIA)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202241

Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Ontario Ministry of Health and Long Term Care
Principal Investigator: Wendy Wobeser, MD Queen's University

Responsible Party: Dr. Wendy Wobeser, Principal Investigator, Queen's University Identifier: NCT00202241     History of Changes
Other Study ID Numbers: DMED-99
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Dr. Wendy Wobeser, Queen's University:
anabolic steroid
body composition
skinfold measurements
protease inhibitors

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Testosterone Congeners
Protease Inhibitors
HIV Protease Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents