Clinical trial

Body Composition Sub-study of the D2EFT Trial

Name

D2EFT BodyComp

Description

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 arms

Trial start

2019-12-05

Estimated PCD

2024-01-15

Trial end

2024-01-15

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Darunavir (DRV) 800 milligram (MG) Oral Tablet

800 milligrams (mg) orally once daily for 96 weeks

Arms:

Dolutegravir + darunavir, Standard of care

Other names:

Prezista

Ritonavir 100 MG Oral Tablet

100 mg orally once daily for 96 weeks

Arms:

Dolutegravir + darunavir, Standard of care

Other names:

Norvir, RTV

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

Arms:

Standard of care

Other names:

Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]

Dolutegravir 50 MG Oral Tablet

50 mg orally once daily for 96 weeks

Arms:

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

Other names:

Tivicay, DTG

TDF 300 MG Oral Tablet

300 mg orally once daily for 96 weeks

Arms:

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

Other names:

tenofovir disoproxil fumarate, Viread

3TC 300 MG Oral Tablet

300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician

Arms:

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

Other names:

lamivudine

FTC 200 MG Oral Cap

200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician

Arms:

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

Other names:

Emtriva, emtricitabine

Size

155

Primary endpoint

Mean/median between-group change in waist-to-hip ratio

at 48 weeks

Mean/median between-group change in total-to-HDL cholesterol ratio

at 48 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 155, 'type': 'ACTUAL'}}

Updated at

2023-07-25

1 organization

7 products

1 indication

Organization

Kirby Institute

Product

Darunavir

Indication

HIV Infections

Product