CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 221 enrolled
Drug / intervention
Niacin +4 moredrug
Likely dose
Niacin (Niaspan) titrated up to 2 grams per day and fenofibrate (Tricor) 120 mg per dayAI-extracted
Key inclusion· 5
  • ✓HIV positive
  • ✓On stable HAART regimen for at least 6 months prior to study entry
  • ✓CD4 T-cell count >100 and viral load <1000 for at least 6 months prior to study entry
  • ✓Fasting triglyceride level between 150 and 1000 mg/dL
Key exclusion· 11
  • ✕Fasting triglyceride level >1000 mg/dL
  • ✕BMI <18.5 or ≥30
  • ✕Unable to exercise or medical condition making exercise unadvisable
  • ✕CD4 T-cell count <100

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00246376
NCT00246376N/ACompleted
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Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy

Baylor College of Medicine·interventional·Posted Oct 31, 2005·Updated Mar 21, 2016

In Brief

A clinical study evaluating Diet, Exercise, and 3 other interventions for Cardiovascular Diseases and 6 related conditions. Completed, enrolled 221 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Heart Diseases, HIV Infections, Hyperlipidemia, Hypertriglyceridemia, Insulin Resistance, Atherosclerosis
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Legacy Community Health Center

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2005
Enrollment StartJan 1, 2004
Primary CompletionSep 1, 2009
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.7 years ago

Interventions

Dietbehavioral

ATP-III diet

Exercisebehavioral

Supervised exercise in study gym

Niacindrug

Niaspan, titrated up to 2 grams per day

Fenofibratedrug

Tricor, 120 mg per day

Placebosother

Placebos for Niaspan and Tricor