Body Composition Sub-study of the D2EFT Trial

NCT03675815 | Completed Phase 4

• 1 other identifier: D2EFT BodyComp
• Study Type: interventional
• Target: 155
• Locations: 5 countries
• Sites: 7

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

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

  umbilical waist and hip measures

  at 48 weeks

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

  total and HDL cholesterol plasma concentrations

  at 48 weeks

Secondary Outcomes (13)

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

  at 96 weeks

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

  at 96 weeks

• Mean/median between-group change in body weight

  at week 48 and 96

• Mean/median between-group change in maximum umbilical and hip measures

  at week 48 and 96

• Mean/median between-group change in fasting lipid parameters

  at weeks 48 and 96

Other Outcomes (1)

• Mean/median between-group change in serum biomarker concentrations

  weeks 48 and 96

Study Arms (3)

Standard of care

ACTIVE COMPARATOR

darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd

Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet; Drug: Ritonavir 100 MG Oral Tablet; Drug: N(t)RTIs

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

EXPERIMENTAL

dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd

Drug: Dolutegravir 50 MG Oral Tablet; Drug: TDF 300 MG Oral Tablet; Drug: 3TC 300 MG Oral Tablet; Drug: FTC 200 MG Oral Cap

Dolutegravir + darunavir

EXPERIMENTAL

dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd

Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet; Drug: Ritonavir 100 MG Oral Tablet; Drug: Dolutegravir 50 MG Oral Tablet

Interventions

Darunavir (DRV) 800 milligram (MG) Oral Tablet DRUG

800 milligrams (mg) orally once daily for 96 weeks

Also known as: Prezista

Dolutegravir + darunavir; Standard of care

Ritonavir 100 MG Oral Tablet DRUG

100 mg orally once daily for 96 weeks

Also known as: Norvir, RTV

Dolutegravir + darunavir; Standard of care

N(t)RTIs DRUG

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

Also known as: Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]

Standard of care

Dolutegravir 50 MG Oral Tablet DRUG

50 mg orally once daily for 96 weeks

Also known as: Tivicay, DTG

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

TDF 300 MG Oral Tablet DRUG

300 mg orally once daily for 96 weeks

Also known as: tenofovir disoproxil fumarate, Viread

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

3TC 300 MG Oral Tablet DRUG

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

Also known as: lamivudine

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

FTC 200 MG Oral Cap DRUG

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

Also known as: Emtriva, emtricitabine

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfil the criteria for D2EFT randomisation
• Able to undergo DXA whole-body scanning
• Provide informed written consent for the D2EFT Body Composition Sub-study

You may not qualify if:

• Unwilling to comply with the study requirements

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (7)

Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site

Chennai, 600113, India

Location

Univerity of Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Soweto, Johannesburg, 2013, South Africa

Location

Clinical HIV Research Unit, Helen Joseph Hospital

Westdene, Johannesburg, South Africa

Location

Desmond Tutu HIV Foundation

Cape Town, 9725, South Africa

Location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre

Bangkok, 10330, Thailand

Location

University of Zimbabwe Clinical Research Centre

Harare, 263, Zimbabwe

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir; Tablets; Ritonavir; Nucleosides; dolutegravir; Tenofovir; Lamivudine; Racivir; Capsules; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Thiazoles; Azoles; Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Dideoxynucleosides

Study Officials

• Gail Matthews, MBBCh

  The Kirby Institute, UNSW Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: September 18, 2018
• Study Start: December 5, 2019
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

ZI (1); IN (1); MY (1); ZA (3); TH (1)