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Body Composition Sub-study of the D2EFT Trial

Primary Purpose

HIV Infections

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Darunavir (DRV) 800 milligram (MG) Oral Tablet
Ritonavir 100 MG Oral Tablet
N(t)RTIs
Dolutegravir 50 MG Oral Tablet
TDF 300 MG Oral Tablet
3TC 300 MG Oral Tablet
FTC 200 MG Oral Cap
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fulfil the criteria for D2EFT randomisation
  • Able to undergo DXA whole-body scanning
  • Provide informed written consent for the D2EFT Body Composition Sub-study

Exclusion Criteria:

  • Unwilling to comply with the study requirements

Sites / Locations

  • Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site
  • Univerity of Malaya Medical Centre
  • Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
  • Clinical HIV Research Unit, Helen Joseph Hospital
  • Desmond Tutu HIV Foundation
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre
  • University of Zimbabwe Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard of care

Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)

Dolutegravir + darunavir

Arm Description

darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd

dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd

dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd

Outcomes

Primary Outcome Measures

Mean/median between-group change in waist-to-hip ratio
umbilical waist and hip measures
Mean/median between-group change in total-to-HDL cholesterol ratio
total and HDL cholesterol plasma concentrations

Secondary Outcome Measures

Mean/median between-group change in total-to-HDL cholesterol ratio
total and HDL cholesterol plasma concentrations
Mean/median between-group change in waist-to-hip ratio
umbilical waist and hip measures
Mean/median between-group change in body weight
body weight measurement
Mean/median between-group change in maximum umbilical and hip measures
umbilical waist and hip measures
Mean/median between-group change in fasting lipid parameters
total, HDL, and LDL cholesterol and triglyceride plasma concentrations
Mean/median between-group change in fasting glycaemic parameters
glucose, insulin, HbA1c concentrations
Mean/median between-group absolute change in limb fat assessed by DXA
absolute change from baseline in limb fat
Mean/median between-group percentage change in limb fat assessed by DXA
percentage change from baseline in limb fat
Mean/median between-group changes in regional body fat assessed by DXA
regional = limb fat and truncal fat
Mean/median between-group changes in total body fat and lean tissue assessed by DXA
total body fat and total lean tissue
Mean/median between-group changes in bone mineral content assessed by DXA
total bone mineral content
Mean/median between-group change in Body Image questionnaire scores
NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires
Proportion with Metabolic Syndrome
baseline prevalence and incidence at weeks 48 and 96

Full Information

First Posted
July 2, 2018
Last Updated
July 24, 2023
Sponsor
Kirby Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03675815
Brief Title
Body Composition Sub-study of the D2EFT Trial
Official Title
Body Composition Sub-study of the D2EFT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. The sub-study will be offered to all D2EFT sites with access to DXA technology for whole-body composition analysis. Sites will offer the sub-study to consecutive clinic patients. Patients must be approached for participation and provide informed written consent prior to randomisation into D2EFT. This study will recruit approximately 300 patients. Allocation to one of three ART treatment regimens will follow the result of D2EFT randomisation. The study will investigate the role of contemporary ART on body composition and metabolic parameters by comparing over 96 weeks the effects of the D2EFT ART regimens. The primary endpoint will be assessed at week 48.
Detailed Description
Consenting participants will be randomised within the main D2EFT protocol to receive either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the sub-study is voluntary and not a requirement for enrolment into D2EFT. Parameters relevant to this study including demographics, arm of randomised ART, smoking status, body habitus and fasting lipid parameters and resting blood pressure at required time points will be collected as part of the main D2EFT study. Sub-study specific assessments performed at baseline and at weeks 48 and 96 include clinical and laboratory assessments, sample collection and dual-energy X-ray absorptiometry (DXA)-assessed whole-body composition. Consenting participants will have blood for storage collected at weeks 0, 48 and 96. The specimens will be used for future studies into treatment of HIV infection and immunity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd
Arm Title
Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC)
Arm Type
Experimental
Arm Description
dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd
Arm Title
Dolutegravir + darunavir
Arm Type
Experimental
Arm Description
dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd
Intervention Type
Drug
Intervention Name(s)
Darunavir (DRV) 800 milligram (MG) Oral Tablet
Other Intervention Name(s)
Prezista
Intervention Description
800 milligrams (mg) orally once daily for 96 weeks
Intervention Type
Drug
Intervention Name(s)
Ritonavir 100 MG Oral Tablet
Other Intervention Name(s)
Norvir, RTV
Intervention Description
100 mg orally once daily for 96 weeks
Intervention Type
Drug
Intervention Name(s)
N(t)RTIs
Other Intervention Name(s)
Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]
Intervention Description
Choice of N(t)RTIs determined by clinician guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection
Intervention Type
Drug
Intervention Name(s)
Dolutegravir 50 MG Oral Tablet
Other Intervention Name(s)
Tivicay, DTG
Intervention Description
50 mg orally once daily for 96 weeks
Intervention Type
Drug
Intervention Name(s)
TDF 300 MG Oral Tablet
Other Intervention Name(s)
tenofovir disoproxil fumarate, Viread
Intervention Description
300 mg orally once daily for 96 weeks
Intervention Type
Drug
Intervention Name(s)
3TC 300 MG Oral Tablet
Other Intervention Name(s)
lamivudine
Intervention Description
300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
Intervention Type
Drug
Intervention Name(s)
FTC 200 MG Oral Cap
Other Intervention Name(s)
Emtriva, emtricitabine
Intervention Description
200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
Primary Outcome Measure Information:
Title
Mean/median between-group change in waist-to-hip ratio
Description
umbilical waist and hip measures
Time Frame
at 48 weeks
Title
Mean/median between-group change in total-to-HDL cholesterol ratio
Description
total and HDL cholesterol plasma concentrations
Time Frame
at 48 weeks
Secondary Outcome Measure Information:
Title
Mean/median between-group change in total-to-HDL cholesterol ratio
Description
total and HDL cholesterol plasma concentrations
Time Frame
at 96 weeks
Title
Mean/median between-group change in waist-to-hip ratio
Description
umbilical waist and hip measures
Time Frame
at 96 weeks
Title
Mean/median between-group change in body weight
Description
body weight measurement
Time Frame
at week 48 and 96
Title
Mean/median between-group change in maximum umbilical and hip measures
Description
umbilical waist and hip measures
Time Frame
at week 48 and 96
Title
Mean/median between-group change in fasting lipid parameters
Description
total, HDL, and LDL cholesterol and triglyceride plasma concentrations
Time Frame
at weeks 48 and 96
Title
Mean/median between-group change in fasting glycaemic parameters
Description
glucose, insulin, HbA1c concentrations
Time Frame
at weeks 48 and 96
Title
Mean/median between-group absolute change in limb fat assessed by DXA
Description
absolute change from baseline in limb fat
Time Frame
week 48 and 96
Title
Mean/median between-group percentage change in limb fat assessed by DXA
Description
percentage change from baseline in limb fat
Time Frame
week 48 and 96
Title
Mean/median between-group changes in regional body fat assessed by DXA
Description
regional = limb fat and truncal fat
Time Frame
week 48 and 96
Title
Mean/median between-group changes in total body fat and lean tissue assessed by DXA
Description
total body fat and total lean tissue
Time Frame
week 48 and 96
Title
Mean/median between-group changes in bone mineral content assessed by DXA
Description
total bone mineral content
Time Frame
week 48 and 96
Title
Mean/median between-group change in Body Image questionnaire scores
Description
NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires
Time Frame
weeks 48 and 96
Title
Proportion with Metabolic Syndrome
Description
baseline prevalence and incidence at weeks 48 and 96
Time Frame
week 0, and week 48 and 96
Other Pre-specified Outcome Measures:
Title
Mean/median between-group change in serum biomarker concentrations
Description
biomarkers to be determined
Time Frame
weeks 48 and 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fulfil the criteria for D2EFT randomisation Able to undergo DXA whole-body scanning Provide informed written consent for the D2EFT Body Composition Sub-study Exclusion Criteria: Unwilling to comply with the study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Matthews, MBBCh
Organizational Affiliation
The Kirby Institute, UNSW Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site
City
Chennai
ZIP/Postal Code
600113
Country
India
Facility Name
Univerity of Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
City
Soweto
State/Province
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Clinical HIV Research Unit, Helen Joseph Hospital
City
Westdene
State/Province
Johannesburg
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation
City
Cape Town
ZIP/Postal Code
9725
Country
South Africa
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
University of Zimbabwe Clinical Research Centre
City
Harare
ZIP/Postal Code
263
Country
Zimbabwe

12. IPD Sharing Statement

Learn more about this trial

Body Composition Sub-study of the D2EFT Trial

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