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

NCT00202241 | Completed

• 1 other identifier: DMED-99
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

HIV; AIDS; Lipodystrophy; Hyperlipidemia

Keywords

HIV; AIDS; testosterone; anabolic steroid; body composition; lipodystrophy; MRI; BIA; skinfold measurements; protease inhibitors

Outcome Measures

Primary Outcomes (3)

• differences in serum lipid levels

• differences in regional and overall body fat level

• impacts on metabolic and cardiovascular health

Secondary Outcomes (2)

• quantity of muscle tissue between group comparison

• comparison of 3 determinants of body composition(MRI,skinfold,BIA)

Interventions

testosterone injection PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• documented HIV seropositive status
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Lipodystrophy; Hyperlipidemias

Interventions

Testosterone

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Wendy Wobeser, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 1999
• Study Completion: June 1, 2001
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

CA (1)