Effect of HIV Protease Inhibitor Drugs on Glucose and Ins... | NCT00135434

Studies
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

NCT00135434

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 8, 2011Estimated

Enrollment

Phase

Phase 1

Conditions

HIV Infections

Interventions

Atazanavir/Ritonavir/Lopinavir/ritonavir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

Description Module

Brief Summary

This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Atazanavir/Ritonavir/Lopinavir/ritonavir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity by euglycemic hyperinsulinemic clamp method

Secondary Outcomes

Measure	Description	Time Frame
Insulin sensitivity by oral glucose tolerance
Lipids and lipoproteins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Pharmacology Unit, Bristol-Myers Squibb Company		Hamilton	New Jersey	08690	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069446	Atazanavir Sulfate
C558899	lopinavir-ritonavir drug combination

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides

Browse Leaves

Not provided

Browse Branches

Not provided