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Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135434
First received: August 25, 2005
Last updated: April 7, 2011
Last verified: November 2009
History of Changes
  Purpose

This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.


Condition Intervention Phase
HIV Infections
 Drug: Atazanavir/Ritonavir/Lopinavir/ritonavir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Insulin sensitivity by euglycemic hyperinsulinemic clamp method

Secondary Outcome Measures:
  • Insulin sensitivity by oral glucose tolerance
  • Lipids and lipoproteins

Estimated Enrollment: 25
Study Start Date: September 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135434

Locations
United States, New Jersey
Clinical Pharmacology Unit, Bristol-Myers Squibb Company
Hamilton, New Jersey, United States, 08690
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00135434     History of Changes
Other Study ID Numbers: AI424-130
Study First Received: August 25, 2005
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Protease Inhibitors
 Ritonavir
Lopinavir
Atazanavir
HIV 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 May 21, 2013