Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism - Full Text View

Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

This study has been completed.

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

ChemIDplus related topics:

Insulin Dextrose Ritonavir Lopinavir Atazanavir sulfate BMS 232632

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:	Mustafa A. Noor, MD	Bristol-Myers Squibb

More 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

Study ID Numbers:	AI424-130
First Received:	August 25, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00135434
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Lopinavir

Ritonavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Atazanavir

Retroviridae Infections

Insulin

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

ClinicalTrials.gov processed this record on October 17, 2008