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Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135434
First Posted: August 26, 2005
Last Update Posted: April 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00135434     History of Changes
Other Study ID Numbers: AI424-130
First Submitted: August 25, 2005
First Posted: August 26, 2005
Last Update Posted: April 8, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors