Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00135434
Collaborator
(none)
25
1
9
2.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Study Start Date
:
Sep 1, 2004
Actual Primary Completion Date
:
Jun 1, 2005
Actual Study Completion Date
:
Jun 1, 2005
Outcome Measures
Primary Outcome Measures
- Insulin sensitivity by euglycemic hyperinsulinemic clamp method []
Secondary Outcome Measures
- Insulin sensitivity by oral glucose tolerance []
- Lipids and lipoproteins []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy volunteers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00135434
Other Study ID Numbers:
- AI424-130
First Posted:
Aug 26, 2005
Last Update Posted:
Apr 8, 2011
Last Verified:
Nov 1, 2009