Effect of Atazanavir on Endothelial Function in HIV-Infected Patients (ENDOPACT)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Foundation for Cardiovascular Research, Zurich
ClinicalTrials.gov Identifier:
NCT00447070
First received: March 12, 2007
Last updated: May 26, 2009
Last verified: March 2007
  Purpose

It is known that certain antiviral therapies, the socalled protease inhibitors, used in the treatment of HIV infection has an untowarded effect on the blood vessels, promoting early occurence of atherosclerosis. A a newer protease inhibitor, atazanavir, has been shown to have no negative effect on the levels of blood cholesterol and it is hypothesized that this may indicate that atazanavir is less prone to induce atherosclerosis. An early sign of atherosclerosis is a reduced vasomotion and this study investigate the influence of atazanavir on functionality of the conduit blood vessels compared to that of "standard" antiviral therapy.


Condition Intervention Phase
HIV Infections
Dyslipidemia
Drug: ATAZANAVIR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effect of Atazanavir on Endothelial Function in HIV-Infected Patients Compared to Standard Proteinase Inhibitors on Top of Potent Antiviral Combination Therapy

Resource links provided by NLM:


Further study details as provided by Foundation for Cardiovascular Research, Zurich:

Primary Outcome Measures:
  • Change of flow-mediated dilation in the forearm after 6 months using the protease inhibitor atazanavir in a potent antiviral therapy combination compared with a combination including current proteinase inhibitor.

Secondary Outcome Measures:
  • Changes in plasma lipid profiles and further clinical chemistry parameters after 6 months of treatment compared to baseline.

Estimated Enrollment: 50
Study Start Date: August 2004
Estimated Study Completion Date: May 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18 to 65 years old.
  • HIV-infection, documented by HIV-antibody ELISA and either positive immunoblot for HIV-antibodies or presence of HIV1 in blood.
  • Two consecutive Roche Ultrasensitive Amplicor tests showing plasma HIV-1 RNA < 50 copies/ml within 60 days prior to study entry.
  • CD4 count of > 100 cells/ml during 60 days prior to study entry.
  • Stable antiretroviral therapy for at least 12 weeks prior to study entry (a protease inhibitor plus 2 NRTIs).
  • Patient's treatment history allows, in the opinion of the investigator, atazanavir as replacement for current PI, i.e. continued viral suppression is expected based upon patient's treatment history and results of previous resistance testing, if available.
  • Fasting LDL-cholesterol > 3.0 mmol/l.

Exclusion Criteria:

  • Known coronary artery disease, hypertension, peripheral artery disease, or cerebrovascular disease.
  • Diabetes mellitus.
  • Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to study entry.
  • Any contraindication for study medication.
  • Currently on non-nucleoside reverse transcriptase inhibitors (NNRTI) (previous exposure allowed).
  • Previous virologic failure on proteinase inhibitor-containing regimens which was not the consequence of poor adherence to therapy or drug adverse events; i.e. virologic failure was probably due to lack of potency of drug regimen, and may consecutively have resulted in protease resistance mutations.
  • Previously documented protease resistance mutations which are known to result in cross-resistance against atazanavir.
  • Any lipid lowering drugs within 4 weeks prior to study entry.
  • Testosterone or anabolic steroids unless stable therapy at least 12 weeks prior to study entry.
  • Systemic glucocorticoids, long-acting inhaled steroids or other immunomodulators within 30 days prior to study entry (prednisone < 10mg/day or equivalent is permitted.
  • Drug or alcohol abuse, in the opinion of the investigator rendering the patient unreliable for participation.
  • Participation in any other drug/treatment 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: NCT00447070

Locations
Switzerland
University Hospital Zurich, Infectiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
Foundation for Cardiovascular Research, Zurich
Bristol-Myers Squibb
Investigators
Principal Investigator: Rainer Weber, Prof. University of Zurich
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00447070     History of Changes
Other Study ID Numbers: ICN 99034
Study First Received: March 12, 2007
Last Updated: May 26, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Foundation for Cardiovascular Research, Zurich:
HIV-infection
Dyslipidemia
Endothelial Dysfunction
Atherosclerosis
Protease inhibitor
treatment experienced

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Dyslipidemias
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
Lipid Metabolism Disorders
Metabolic Diseases
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014