HIV Clinical Trial
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
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?
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.
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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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