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 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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Atazanavir

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 (Adult)
Sexes Eligible for Study:	All
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:

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


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

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 HIV Protease Inhibitors	Lopinavir Atazanavir Sulfate 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

ClinicalTrials.gov processed this record on June 26, 2017

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