Status:
COMPLETED
Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
HIV I Infection
Adiposity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A substudy of TMC114FD2HTX4004 that will perform glucose tolerance testing, adipose testing and MRI scan at baseline, 12 and 24 weeks post switch of ART medications.
Detailed Description
Synopsis Full study title: Assessing the impact of integrase strand transfer inhibitors (INSTI) to protease inhibitor (PI) switch on insulin sensitivity and fat metabolism (ADIPOSITY): a sub-study of ...
Eligibility Criteria
Inclusion
- • Must be enrolled in the DEFINE study TMC114FD2HTX4004
- Must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study.
Exclusion
- • Contraindication to magnetic resonance imaging as determined by institutional policy.
- Current diagnosis of diabetes mellitus
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04675255
Start Date
January 1 2021
End Date
June 8 2023
Last Update
August 3 2023
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110