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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00046267 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Hypercholesterolemia Hypertriglyceridemia Diabetes Mellitus |
Drug: Niacin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 30 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| Univ of California, San Diego Antirviral Research | |
| San Diego, California, United States, 92103 | |
| Willow Clinic | |
| Stanford, California, United States, 94305 | |
| Stanford Univ | |
| Stanford, California, United States, 94305 | |
| San Mateo County AIDS Program | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr, Denver | |
| Denver, Colorado, United States, 80262-3706 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136-1013 | |
| United States, Indiana | |
| Indiana University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Methodist Hosp of Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455-0392 | |
| United States, Missouri | |
| Washington Univ (St. Louis) | |
| St. Louis, Missouri, United States, 63108 | |
| St. Louis Connect Care | |
| St. Louis, Missouri, United States, 63108 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| Study Chair: | Michael P. Dube, M. D. | |
| Study Chair: | James H. Stein, M. D. |
More Information
| ClinicalTrials.gov Identifier: | NCT00046267 History of Changes |
| Other Study ID Numbers: | ACTG A5148 |
| Study First Received: | September 24, 2002 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Federal Government |
|
Delayed-Action Preparations Blood Glucose Insulin Alanine Transaminase |
Aspartate Aminotransferases Fructosamine Glucose Tolerance Test Treatment Experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Diabetes Mellitus Hypercholesterolemia Hypertriglyceridemia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Niacin Nicotinic Acids Niacinamide Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |