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

The Washington University

Status: Completed

Conditions: Adiposity; HIV I Infection

Treatments: Procedure: abdominal subcutaneous adipose tissue biopsy; Procedure: MRI scan to assess intrahepatic triglyceride content; Procedure: Frequently sampled glucose tolerance testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04675255

202008043

Details and patient eligibility

About

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.

Full 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 DEFINE

Endpoints and objectives:

The following endpoints will be determined 12 and 24 weeks after switch from an INSTI-based antiretroviral therapy (ART) regimen to a PI-based regimen:

Primary endpoint: Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).

Secondary endpoints: 1) Change in insulin sensitivity (SI) at 24 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT); 2) Change in insulin secretion during the fsOGTT assessed by using C-peptide deconvolution; 3) Change in intrahepatic triglyceride (IHTG) content measured by magnetic resonance imaging (MRI); 4) Change in adipocyte size by the osmium tetroxide fixation technique; and 5) Change in expression of genes associated with adipose tissue development, lipogenesis, inflammation and endocrine function by RNA sequencing.

Hypothesis: Insulin sensitivity will improve following switch from INSTIs to PIs

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Immediate switch

Active Comparator group

Description:

Immediate switch

Treatment:

Procedure: MRI scan to assess intrahepatic triglyceride content

Procedure: abdominal subcutaneous adipose tissue biopsy

Procedure: Frequently sampled glucose tolerance testing

Delayed switch

Active Comparator group

Description:

Delayed switch

Treatment:

Procedure: MRI scan to assess intrahepatic triglyceride content

Procedure: abdominal subcutaneous adipose tissue biopsy

Procedure: Frequently sampled glucose tolerance testing