Back to resultsEffect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atazanavir/Ritonavir/Lopinavir/ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria: Healthy volunteers
Sites / Locations
- Clinical Pharmacology Unit, Bristol-Myers Squibb Company
Outcomes
Primary Outcome Measures
Insulin sensitivity by euglycemic hyperinsulinemic clamp method
Secondary Outcome Measures
Insulin sensitivity by oral glucose tolerance
Lipids and lipoproteins
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00135434
Brief Title
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Official Title
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atazanavir/Ritonavir/Lopinavir/ritonavir
Primary Outcome Measure Information:
Title
Insulin sensitivity by euglycemic hyperinsulinemic clamp method
Secondary Outcome Measure Information:
Title
Insulin sensitivity by oral glucose tolerance
Title
Lipids and lipoproteins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology Unit, Bristol-Myers Squibb Company
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
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