NCT04675255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

October 13, 2020

Last Update Submit

August 1, 2023

Conditions

HIV I InfectionAdiposity

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity measured by homeostatic model assessment for insulin resistance {HOMA_IR}

    Change in insulin sensitivity (SI) at 12 weeks assessed by using a 3-hour frequently sampled oral glucose tolerance testing (fsOGTT).to calculate HOMA\_IR

    12 weeks

Secondary Outcomes (7)

  • Intrahepatic triglyceride (IHTG) content measure by magnetic resonance

    12 weeks

  • Intrahepatic triglyceride (IHTG) content measure by magnetic resonance

    24 weeks

  • Adipocyte size measured by osmium tetroxide fixation technique

    12 weeks

  • Adipocyte size measured by osmium tetroxide fixation technique

    24 weeks

  • Adipocyte gene expression correlated with adipose tissue development

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Immediate switch

ACTIVE COMPARATOR

Immediate switch

Procedure: Frequently sampled glucose tolerance testingProcedure: abdominal subcutaneous adipose tissue biopsyProcedure: MRI scan to assess intrahepatic triglyceride content

Delayed switch

ACTIVE COMPARATOR

Delayed switch

Procedure: Frequently sampled glucose tolerance testingProcedure: abdominal subcutaneous adipose tissue biopsyProcedure: MRI scan to assess intrahepatic triglyceride content

Interventions

Frequently sampled glucose tolerance testingPROCEDURE

Frequently sampled glucose tolerance testing

Delayed switchImmediate switch
abdominal subcutaneous adipose tissue biopsyPROCEDURE

abdominal subcutaneous adipose tissue biopsy

Delayed switchImmediate switch
MRI scan to assess intrahepatic triglyceride contentPROCEDURE

MRI scan to assess intrahepatic triglyceride content

Delayed switchImmediate switch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to magnetic resonance imaging as determined by institutional policy.
  • Current diagnosis of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jane O'Halloran, MB BA PhD

    Washington University School of Medicine in St. Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

December 19, 2020

Study Start

January 1, 2021

Primary Completion

June 8, 2023

Study Completion

June 8, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

There is no plan

Locations

US(1)