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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03675815




Registration number
NCT03675815
Ethics application status
Date submitted
2/07/2018
Date registered
18/09/2018
Date last updated
9/01/2025

Titles & IDs
Public title
Body Composition Sub-study of the D2EFT Trial
Scientific title
Body Composition Sub-study of the D2EFT Trial
Secondary ID [1] 0 0
D2EFT BodyComp
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darunavir (DRV) 800 milligram (MG) Oral Tablet
Treatment: Drugs - Ritonavir 100 MG Oral Tablet
Treatment: Drugs - N(t)RTIs
Treatment: Drugs - Dolutegravir 50 MG Oral Tablet
Treatment: Drugs - TDF 300 MG Oral Tablet
Treatment: Drugs - 3TC 300 MG Oral Tablet
Treatment: Drugs - FTC 200 MG Oral Cap

Active comparator: Standard of care - darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd

Experimental: Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) - dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd

Experimental: Dolutegravir + darunavir - dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd


Treatment: Drugs: Darunavir (DRV) 800 milligram (MG) Oral Tablet
800 milligrams (mg) orally once daily for 96 weeks

Treatment: Drugs: Ritonavir 100 MG Oral Tablet
100 mg orally once daily for 96 weeks

Treatment: Drugs: N(t)RTIs
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

Treatment: Drugs: Dolutegravir 50 MG Oral Tablet
50 mg orally once daily for 96 weeks

Treatment: Drugs: TDF 300 MG Oral Tablet
300 mg orally once daily for 96 weeks

Treatment: Drugs: 3TC 300 MG Oral Tablet
300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician

Treatment: Drugs: FTC 200 MG Oral Cap
200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean/median between-group change in waist-to-hip ratio
Timepoint [1] 0 0
at 48 weeks
Primary outcome [2] 0 0
Mean/median between-group change in total-to-HDL cholesterol ratio
Timepoint [2] 0 0
at 48 weeks
Secondary outcome [1] 0 0
Mean/median between-group change in total-to-HDL cholesterol ratio
Timepoint [1] 0 0
at 96 weeks
Secondary outcome [2] 0 0
Mean/median between-group change in waist-to-hip ratio
Timepoint [2] 0 0
at 96 weeks
Secondary outcome [3] 0 0
Mean/median between-group change in body weight
Timepoint [3] 0 0
at week 48 and 96
Secondary outcome [4] 0 0
Mean/median between-group change in maximum umbilical and hip measures
Timepoint [4] 0 0
at week 48 and 96
Secondary outcome [5] 0 0
Mean/median between-group change in fasting lipid parameters
Timepoint [5] 0 0
at weeks 48 and 96
Secondary outcome [6] 0 0
Mean/median between-group change in fasting glycaemic parameters
Timepoint [6] 0 0
at weeks 48 and 96
Secondary outcome [7] 0 0
Mean/median between-group absolute change in limb fat assessed by DXA
Timepoint [7] 0 0
week 48 and 96
Secondary outcome [8] 0 0
Mean/median between-group percentage change in limb fat assessed by DXA
Timepoint [8] 0 0
week 48 and 96
Secondary outcome [9] 0 0
Mean/median between-group changes in regional body fat assessed by DXA
Timepoint [9] 0 0
week 48 and 96
Secondary outcome [10] 0 0
Mean/median between-group changes in total body fat and lean tissue assessed by DXA
Timepoint [10] 0 0
week 48 and 96
Secondary outcome [11] 0 0
Mean/median between-group changes in bone mineral content assessed by DXA
Timepoint [11] 0 0
week 48 and 96
Secondary outcome [12] 0 0
Mean/median between-group change in Body Image questionnaire scores
Timepoint [12] 0 0
weeks 48 and 96
Secondary outcome [13] 0 0
Proportion with Metabolic Syndrome
Timepoint [13] 0 0
week 0, and week 48 and 96

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwilling to comply with the study requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2024
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Chennai
Country [2] 0 0
Malaysia
State/province [2] 0 0
Kuala Lumpur
Country [3] 0 0
South Africa
State/province [3] 0 0
Johannesburg
Country [4] 0 0
South Africa
State/province [4] 0 0
Cape Town
Country [5] 0 0
Thailand
State/province [5] 0 0
Bangkok
Country [6] 0 0
Zimbabwe
State/province [6] 0 0
Harare

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03675815
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Gail Matthews, MBBCh
Address 0 0
The Kirby Institute, UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03675815