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

Not Applicable

Completed

• Conditions: AIDS; Lipodystrophy; Hyperlipidemia; HIV

• Registration Number: NCT00202241
• Lead Sponsor: 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?

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 Timeline

• Study Start: 1999-09
• Study Completion: 2001-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
differences in serum lipid levels
impacts on metabolic and cardiovascular health
differences in regional and overall body fat level

Secondary Outcome Measures

Name	Time	Method
quantity of muscle tissue between group comparison
comparison of 3 determinants of body composition(MRI,skinfold,BIA)

Trial Locations

Locations (1)

Queen's University; 🇨🇦 Kingston, Ontario, Canada