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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01683656
Eligibility Criteria:
Inclusion Criteria:
* Adult patients \> 40 years;
* Women of childbearing potential must use two reliable contraceptive methods during the entire trial, from day 1 to one month after the end of the trial.
* Signing the study consent form;
* Stable cART since at least 3 months (ie no recent drug change);
* HIV-RNA below 100 copies for at least 6 months;
* HDL-cholesterol \<1.29 mmol/l for men; \<1.42 mmol/l for women
Exclusion Criteria:
* Pregnancy or lactation;
* Congestive Heart Failure;
* Malignant Hypertension;
* Acute or chronic coronary artery diseases;
* Any known cardiac arrhythmias;
* Diabetes;
* Concomitant cancer, rheumatologic disease or inflammatory bowel diseases;
* Concomitant renal or hepatic disease:
* Creatinine above 150 micromol/L
* Transaminases above 5 times upper normal limit
* Prothrombin time (Quick) value below 50%;
* Prior intolerance to niacin therapy (reported in a medical report);
* Cyclosporine, anti-inflammatory drugs (other than aspirin) or cytokine therapy in concomitant intake;
* Abnormal thyroid function;
* Excessive consumption of alcohol;
* Known severe lactose intolerance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01683656
Study Brief:
Protocol Section:
NCT01683656