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

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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