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Ensayos clínicos

Ensayos clínicos

A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000941, ACTG A5047
  • Concluido

Propósito del estudio

To investigate the effect of ritonavir and saquinavir on the pharmacokinetics of pravastatin, simvastatin, and atorvastatin. To evaluate the effect of pravastatin on the disposition of nelfinavir and its M8 metabolite.

Afección:Fase:
Infecciones por el VIH
Fase 1

Detalles del estudio

Potent antiretroviral therapy has become the standard of care for persons with HIV infection and AIDS. Recently, however, a number of complications have emerged with the widespread use of protease inhibitor (PI)-based regimens, including: hyperlipidemia, hypertriglyceridemia, diabetes mellitus, and lipodystrophy. Concern over the possibility of premature myocardial infarction has led health care providers and patients to consider treating these lipid metabolism disorders. Statin compounds have beneficial effects as lipid-lowering agents, and thereby reduce the risk of cardiovascular complications. Statin compounds such as pravastatin, simvastatin, and atorvastatin are increasingly being prescribed in persons taking PI-based potent antiretroviral therapy. It is important to determine whether there are significant drug-drug interactions between the statin compounds and PIs.Fourteen healthy participants for each cohort of Arm A are stabilized on a fixed regimen of pravastatin (Arm A1), simvastatin (Arm A2), or atorvastatin (Arm A3) for 4 days. A baseline pharmacokinetic (PK) evaluation is completed on Day 4. Pravastatin (or simvastatin or atorvastatin) dosing stops following the Day 4 dose and PK evaluation. On Day 5, a ritonavir and saquinavir combination regimen is initiated and continued through Day 18 of the study. Pravastatin (or simvastatin or atorvastatin) dosing resumes on Day 15 and continues through Day 18. A repeat PK evaluation of pravastatin (or simvastatin or atorvastatin) in the context of combination therapy is carried out on Day 18. Fourteen healthy participants are assigned to Arm B; these participants begin a 2-week regimen of nelfinavir. On Day 14, a baseline PK profile of nelfinavir and its M8 metabolite is carried out. Pravastatin is then added to the regimen for Days 15 to 18. On Day 18, a repeat PK evaluation of nelfinavir and the M8 metabolite is carried out in the context of combination therapy.

Criterios de exclusión

    You will not be eligible for this study if you: Have a history of a chronic illness such as high blood pressure, heart disease, arthritis, or diabetes. Are pregnant or breast-feeding. Are taking certain medications.

Centros de estudio/contactos

California

    Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States

    San Francisco Gen Hosp, San Francisco, California, 941102859, United States

    Stanford Univ Med Ctr, Stanford, California, 943055107, United States

Colorado

    Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States

Florida

    Univ of Miami School of Medicine, Miami, Florida, 331361013, United States

Hawaii

    Univ of Hawaii, Honolulu, Hawaii, 96816, United States

Indiana

    Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States

Louisiana

    Tulane Univ School of Medicine, New Orleans, Louisiana, 70112, United States

Maryland

    Johns Hopkins Hosp, Baltimore, Maryland, 21287, United States

Minnesota

    Univ of Minnesota, Minneapolis, Minnesota, 55455, United States

New York

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

South Carolina

    Julio Arroyo, West Columbia, South Carolina, 29169, United States

Washington

    Univ of Washington, Seattle, Washington, 98104, United States

Actualizado: 13 de octubre del 2004

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