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HIV InfectionsNCT00046267

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

A study testing Niacin in people with HIV Infections and Hypercholesterolemia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Niacin
How many people
30 participants
Where
16 sitesUnited States
Study dates
Start not givento Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Univ of Cincinnati

    Cincinnati, Ohio, 45267-0405

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • Univ of Colorado Health Sciences Ctr, Denver

    Denver, Colorado, 80262-3706

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • Methodist Hosp of Indiana

    Indianapolis, Indiana, 46202

  • Wishard Hospital

    Indianapolis, Indiana, 46202

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • Univ of Miami School of Medicine

    Miami, Florida, 33136-1013

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455-0392

  • Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-2582

  • Univ of California, San Diego Antirviral Research

    San Diego, California, 92103

  • St. Louis Connect Care

    St Louis, Missouri, 63108

  • Washington Univ (St. Louis)

    St Louis, Missouri, 63108

  • San Mateo County AIDS Program

    Stanford, California, 94305

  • Stanford Univ

    Stanford, California, 94305

  • Willow Clinic

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Being tested
Niacin
Keywords
Delayed-Action Preparations, Blood Glucose, Insulin, Alanine Transaminase, Aspartate Aminotransferases, Fructosamine, Glucose Tolerance Test, Treatment Experienced
Medical subject headings
HIV Infections, Hypercholesterolemia, Hypertriglyceridemia, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiacinDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2002 (estimated)
  2. Primary completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00046267
Sponsor's protocol ID
ACTG A5148
Status last verified
May 2006
First submitted
24 Sep 2002
Last updated
2 Mar 2011
Results posted
No

Publications

  • 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.

    PubMed 11073755

  • Mulligan 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.

    PubMed 10708054

  • McKenney 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.

    PubMed 8309029

  • Guyton 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.

    PubMed 9761083

  • Hadigan 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.

    PubMed 11118392

Questions about this trial

What is this clinical trial studying?

A study testing Niacin in people with HIV Infections and Hypercholesterolemia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00046267, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.

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