Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202241
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2005-09-13
Brief Title:
The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIVAIDS
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
The Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood LipidsMuscle Mass and Total Body Fat in People Living With HIVAIDS
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HIVAIDS
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
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 HIVAIDS Testosterone and its derivatives anabolic steroids AS are being used by persons with HIVAIDS PHAs 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 PIs in combination with other antiretroviral HIV therapies are associated with a symmetrical loss of subcutaneous fat from the body surface lipodystrophyin 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 reportedThe 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 PIs 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 BIAs and skinfold measurements
It has been shown that protease inhibitors PIs in combination with other antiretroviral HIV therapies are associated with a symmetrical loss of subcutaneous fat from the body surface lipodystrophyin 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 reportedThe 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 PIs 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 BIAs and skinfold measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None