Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
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
1 other identifier
interventional
30
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2002
CompletedFirst Posted
Study publicly available on registry
September 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedMarch 2, 2011
May 1, 2006
September 24, 2002
February 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 equivalent, including but not limited to peripheral vascular disease, cerebrovascular disease, or abdominal aortic aneurysm.
- Congestive heart failure.
- Uncontrolled hypertension within 30 days of study entry, from an average of 2 or more readings on 2 or more occasions.
- Acute arthritic gout symptoms within 60 days of study entry.
- Active peptic ulcer disease.
- Diabetes mellitus that requires pharmacological or dietary control.
- Untreated hypothyroidism. Patients with treated hypothyroidism are allowed.
- Levothyroxine and liothyronine for uses other than for hypothyroidism.
- Active or symptomatic gallbladder disease within 1 year of study entry. Patients with asymptomatic gallstones are allowed. Patients with a history of a cholecystectomy will be allowed provided that the procedure was done at least 3 months before study entry.
- Active cancer within the last 5 years or a new diagnosis of cancer within the last 5 years. Skin cancers, including Kaposi's sarcoma, not requiring systemic treatment are allowed.
- Pregnancy or breast-feeding.
- Any prescription lipid-lowering agent within 30 days of study entry.
- Niacin or niacin-containing products that contain \> 100 mg daily within 30 days prior to study entry.
- Systemic cancer chemotherapy or immunomodulators within 60 days of study entry.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
UCLA School of Medicine
Los Angeles, California, 90095, United States
Univ of California, San Diego Antirviral Research
San Diego, California, 92103, United States
San Mateo County AIDS Program
Stanford, California, 94305, United States
Stanford Univ
Stanford, California, 94305, United States
Willow Clinic
Stanford, California, 94305, United States
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, 80262-3706, United States
Univ of Miami School of Medicine
Miami, Florida, 33136-1013, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202, United States
Wishard Hospital
Indianapolis, Indiana, 46202, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392, United States
St. Louis Connect Care
St Louis, Missouri, 63108, United States
Washington Univ (St. Louis)
St Louis, Missouri, 63108, United States
Univ of Cincinnati
Cincinnati, Ohio, 45267-0405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582, United States
Related Publications (5)
Dube MP, Sprecher D, Henry WK, Aberg JA, Torriani FJ, Hodis HN, Schouten J, Levin J, Myers G, Zackin R, Nevin T, Currier JS; Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Preliminary guidelines for the evaluation and management of dyslipidemia in adults infected with human immunodeficiency virus and receiving antiretroviral therapy: Recommendations of the Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Clin Infect Dis. 2000 Nov;31(5):1216-24. doi: 10.1086/317429. Epub 2000 Nov 7.
PMID: 11073755BACKGROUNDMulligan K, Grunfeld C, Tai VW, Algren H, Pang M, Chernoff DN, Lo JC, Schambelan M. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV infection. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):35-43. doi: 10.1097/00126334-200001010-00005.
PMID: 10708054BACKGROUNDMcKenney JM, Proctor JD, Harris S, Chinchili VM. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA. 1994 Mar 2;271(9):672-7.
PMID: 8309029BACKGROUNDGuyton JR, Goldberg AC, Kreisberg RA, Sprecher DL, Superko HR, O'Connor CM. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol. 1998 Sep 15;82(6):737-43. doi: 10.1016/s0002-9149(98)00448-2.
PMID: 9761083BACKGROUNDHadigan C, Meigs JB, Corcoran C, Rietschel P, Piecuch S, Basgoz N, Davis B, Sax P, Stanley T, Wilson PW, D'Agostino RB, Grinspoon S. Metabolic abnormalities and cardiovascular disease risk factors in adults with human immunodeficiency virus infection and lipodystrophy. Clin Infect Dis. 2001 Jan;32(1):130-9. doi: 10.1086/317541. Epub 2000 Dec 15.
PMID: 11118392BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael P. Dube, M. D.
- STUDY CHAIR
James H. Stein, M. D.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 24, 2002
First Posted
September 25, 2002
Primary Completion
December 1, 2006
Last Updated
March 2, 2011
Record last verified: 2006-05