Body Composition Sub-study of the D2EFT Trial

• Status: Recruiting
• Trial end date: 2024-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Treatments: Darunavir; Dolutegravir; Emtricitabine; Lamivudine; Reverse Transcriptase Inhibitors; Ritonavir; Tenofovir

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