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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-08

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV I Infection Adiposity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Immediate switch

Group Type ACTIVE_COMPARATOR

Frequently sampled glucose tolerance testing

Intervention Type PROCEDURE

Frequently sampled glucose tolerance testing

abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

abdominal subcutaneous adipose tissue biopsy

MRI scan to assess intrahepatic triglyceride content

Intervention Type PROCEDURE

MRI scan to assess intrahepatic triglyceride content

Delayed switch

Group Type ACTIVE_COMPARATOR

Frequently sampled glucose tolerance testing

Intervention Type PROCEDURE

Frequently sampled glucose tolerance testing

abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

abdominal subcutaneous adipose tissue biopsy

MRI scan to assess intrahepatic triglyceride content

Intervention Type PROCEDURE

MRI scan to assess intrahepatic triglyceride content

Interventions

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Frequently sampled glucose tolerance testing

Intervention Type PROCEDURE

abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

MRI scan to assess intrahepatic triglyceride content

Intervention Type PROCEDURE

Eligibility Criteria

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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.