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Body Composition Sub-study of the D2EFT Trial

NCT03675815 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2025-01-09

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Gail Matthews, MBBCh · The Kirby Institute, UNSW Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2024-01-15
Completion
2024-01-15

Countries

  • India
  • Malaysia
  • South Africa
  • Thailand
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675815 on ClinicalTrials.gov