NCT03675815

Body Composition Sub-study of the D2EFT Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Darunavir (DRV) 800 milligram (MG) Oral Tablet	800 milligrams (mg) orally once daily for 96 weeks
DRUG	Ritonavir 100 MG Oral Tablet	100 mg orally once daily for 96 weeks
DRUG	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
DRUG	Dolutegravir 50 MG Oral Tablet	50 mg orally once daily for 96 weeks
DRUG	TDF 300 MG Oral Tablet	300 mg orally once daily for 96 weeks
DRUG	3TC 300 MG Oral Tablet	300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
DRUG	FTC 200 MG Oral Cap	200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician

Timeline

• Start date: 2019-12-05
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2018-09-18
• Last updated: 2025-01-09

Locations

7 sites across 5 countries: India, Malaysia, South Africa, Thailand, Zimbabwe