HIV Infections Clinical Trial
Official title:
A Pilot Study of the Safety, Efficacy, and Tolerability of Extended-Release Niacin (Niaspan) for the Treatment of Elevated Non-HDL Cholesterol and Elevated Triglycerides in HIV-Infected Subjects
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.
Lipid disorders are common among patients with HIV and tend to worsen with potent
antiretroviral therapy. Lipid-lowering drugs are not always effective, and few data address
interactions between antiretroviral drugs and lipid-lowering agents. Additional agents for
the treatment of lipid metabolism disorders in HIV-infected patients are needed. Niacin,
which is highly effective for similar lipid disorders in the general population, may be
effective in treating lipid disorders in patients with HIV.
This 48-week study consists of two steps. In Step 1, patients will begin a lipid-lowering
diet and exercise regimen that will continue throughout the study. After 4 weeks on the
regimen, patients will enter Step 2 of the study and will begin extended-release niacin
therapy. During Step 2, niacin will be dose-escalated every 4 to 6 weeks over a 16-week
period. At Weeks 14 and 20, the niacin dose will be determined by blood fat levels. Patients
will remain on the dose set at Week 20 for the remainder for the study. If blood tests taken
at Week 24 show that blood fat levels have not improved significantly, patients have the
option of adding another fat-lowering drug to their therapy.
Patients will visit the clinic at entry and at Weeks 4, 8, 12, 18, 24, 32, 40, and 48.
Patients may be asked to come to the clinic at Weeks 14 and 20 to receive additional study
drug. Patients must fast for 8 to 12 hours before the screening visit and before each study
visit in which blood will be drawn. Blood will be drawn throughout the study for fat, sugar,
and insulin tests and for CD4 and CD8 cell counts.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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