Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

This study has been completed.

First Received: August 25, 2005 Last Updated: January 7, 2009 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135434

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 I

MedlinePlus related topics: AIDS

Drug Information available for: Insulin Ritonavir Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study
Official Title:	Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

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

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

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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI424-130
Study First Received:	August 25, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00135434 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Insulin

Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Ritonavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009