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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2016 |
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Main ID: |
NCT00202241 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS
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Scientific title:
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The Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood Lipids,Muscle Mass, and Total Body Fat in People Living With HIV/AIDS |
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Date of first enrolment:
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September 1999 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00202241 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Wendy Wobeser, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Queen's University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperlipidemia
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Lipodystrophy
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HIV
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AIDS
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Intervention(s)
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Procedure: testosterone injection
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Primary Outcome(s)
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differences in regional and overall body fat level
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differences in serum lipid levels
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impacts on metabolic and cardiovascular health
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Secondary Outcome(s)
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comparison of 3 determinants of body composition(MRI,skinfold,BIA)
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quantity of muscle tissue between group comparison
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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