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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
  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:


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
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: 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:
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Lopinavir
Protease Inhibitors
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014