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
  Purpose

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 Intervention
HIV
AIDS
Lipodystrophy
Hyperlipidemia
Procedure: testosterone injection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Queen's University:

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)

Estimated Enrollment: 30
Study Start Date: September 1999
Estimated Study Completion Date: June 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202241

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

No publications provided

ClinicalTrials.gov Identifier: NCT00202241     History of Changes
Other Study ID Numbers: DMED-99
Study First Received: September 13, 2005
Last Updated: December 21, 2005
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
HIV
AIDS
testosterone
anabolic steroid
body composition
lipodystrophy
MRI
BIA
skinfold measurements
protease inhibitors

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

ClinicalTrials.gov processed this record on October 21, 2014