Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00046267
First received: September 24, 2002
Last updated: February 28, 2011
Last verified: May 2006
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 30
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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
Criteria

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 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.
  • Investigational antiretroviral drugs in AACTG studies and expanded access trials will be allowed. Other investigational therapies that are not FDA-approved will not be allowed within 30 days of study entry unless permission is granted by study chairs.
  • Systemic glucocorticoids above replacement levels within 60 days of entry.
  • Certain antidiabetic medications.
  • Allergy/sensitivity to the study drug or its formulations.
  • Allergy, sensitivity, or severe intolerance to all of the following 3 medications: aspirin, ibuprofen, and naproxen.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Decreased mental capacity that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry. Patients who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs will be eligible.
  • Acute illness within 30 days prior to entry that, in the opinion of the site investigator, would interfere with participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046267

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
Sponsors and Collaborators
Investigators
Study Chair: Michael P. Dube, M. D.
Study Chair: James H. Stein, M. D.
  More Information

Additional Information:
Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Delayed-Action Preparations
Blood Glucose
Insulin
Alanine Transaminase
Aspartate Aminotransferases
Fructosamine
Glucose Tolerance Test
Treatment Experienced

Additional relevant MeSH terms:
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
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on August 26, 2014