Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT01218802
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of HIV Disease
* Age \> 18 years old
* Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
* Fasting LDL cholesterol \< 130 mg/dl
* Fasting triglycerides \< 300 mg/dL
* hsCRP \> 2 mg/L or CD38+DR+/CD8+ \> 19%
* If on Vit D replacement therapy, stable regimen for \> 3 months prior to study entry
Exclusion Criteria:
* Women who are pregnant or breast feeding
* Any active or chronic inflammatory condition
* Cardiovascular disease
* Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
* Uncontrolled hypothyroidism or hyperthyroidism
* Uncontrolled diabetes
* Use of systemic cancer chemotherapy of immunomodulating agents
* Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
* Use of biphosphonates or other bone therapies
* Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:
* AST and/or ALT \> 2.5 x ULN
* Hemoglobin \< 9.0 g/dL
* CK \> 3 X ULN
* Calculated creatinine clearance \< 50 mL/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01218802
Study Brief:
Protocol Section:
NCT01218802