Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism

Plain-language summary

This study assessed how switching HIV treatment from an integrase inhibitor (INSTI) to a protease inhibitor (PI) affects insulin sensitivity and fat metabolism, using a glucose tolerance test, an abdominal fat tissue biopsy, and an MRI scan to measure liver fat content. People already enrolled in the DEFINE study who did not have diabetes could take part. This study without an assigned phase has been carried out and is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Washington University School of Medicine

Intervention

Frequently sampled glucose tolerance testing, abdominal subcutaneous adipose tissue biopsy, MRI scan to assess intrahepatic triglyceride content

Start date

1/1/2021

Estimated completion

6/8/2023

Countries

United States

Related genes

Locations

• St Louis, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* • 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 Criteria:

* • Contraindication to magnetic resonance imaging as determined by institutional policy.

  * Current diagnosis of diabetes mellitus