Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients (NCT00046267) | Clinical Trial Compass
CompletedNot Applicable
Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
United States30 participants
Plain-language summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected patients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* HIV-infected.
* Stable antiretroviral therapy for 3 months to 1 month prior to study entry and planning to stay on current therapy. No changes in antiretroviral therapy will be allowed in the 1-month period prior to study entry.
* Fasting non-HDL-C \>= 180 mg/dl and serum triglycerides \> 200 mg/dl within 30 days of study entry.
* Willing to stay on the Lipid-Lowering Diet and Activity Guide for the length of the study.
* Women of reproductive potential must have a negative serum or urine pregnancy test performed within 14 days prior to study entry.
* Agrees to use acceptable methods of contraception while receiving protocol-specified medication and for 4 weeks after stopping the medication. Patients who are not of reproductive potential are eligible without requiring the use of contraception.
* Men who have been on stable testosterone replacement for at least 3 months prior to entry and plan to continue a stable dose during the study may enroll.
* Hormone replacement therapy for postmenopausal women and for transgendered patients will be allowed, but not required. Oral contraceptive therapy will be allowed. Patients must be on stable hormone replacement therapy for at least 30 days prior to study entry and plan to continue a stable dose during the study.
Exclusion Criteria:
* LDL-C \>= 200 mg/dl or non-HDL-C \> 250 mg/dl (if the LDL-C cannot be calculated because the triglycerides are \> 400 mg/dl).
* Coronary heart disease (CHD) or CHD risk equivale…
Trial details
NCT IDNCT00046267
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)