Research Studies:
TH9507-CTR-1011
(TH9507-CTR-1011: GROWTH HORMONE RELEASING FACTOR (GhRF) STUDY IN HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME)
This is an intervention study using TH9507, a growth hormone releasing factor analog, for the treatment of HIV-associated adipose redistribution syndrome (HARS).
Purpose: |
To determine if TH9507 is effective and safe at reducing visceral adipose
tissue (excess abdominal fat) in people with HARS.
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Eligibility
Criteria: |
- Age 18-65
- CD4 > 100
- Viral Load < 10,000
- On stable antiretroviral drug regimen for at least 2 months
- Male waist > 95 cm and waist-hip ratio > 0.94
- Female waist > 94 cm and waist-hip ratio > 0.88; not pregnant; normal mammogram
- Cannot have diabetes, cancer, untreated hypertension, thyroid or pitutary problems, and must
be stable on lipid lowering agent, if taking
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Study
Requirements: |
Willing to participate in a 26-week study with 6 study visits and self-administer daily subcutaneous
injections
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Benefits: |
You will receive detailed information about your body composition, fat distribution, and lipid status.
Although this is a randomized, placebo-controlled study, all participants will have the option to receive
active drug treatment in a 26-week extension study (TH9507-CTR-1012) that will be available at the end of the initial 26-week study (TH9507-CTR-1011). A cash stipend will be given, totalling $300 for completion of the study.
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Study
Personnel: |
| Christine A. Wanke,
MD |
Principle Investigator |
| Jül Gerrior, RD |
Research Coordinator |
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Contact: |
Jül Gerrior,
Research Coordinator |
(617) 636-0492
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Privacy and confidentiality are strictly maintained.
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