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Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia

NCT00246376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2016-03-21

Study results available
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Summary

This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

Conditions

Interventions

BEHAVIORAL

Diet

ATP-III diet

BEHAVIORAL

Exercise

Supervised exercise in study gym

DRUG

Niacin

Niaspan, titrated up to 2 grams per day

DRUG

Fenofibrate

Tricor, 120 mg per day

OTHER

Placebos

Placebos for Niaspan and Tricor

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Legacy Community Health Center

    collaborator UNKNOWN

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Ashok Balasubramanyam, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2009-09-30
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00246376 on ClinicalTrials.gov