Body Composition Sub-study of the D2EFT Trial

HIV Infections Clinical Trial

Official title:

Body Composition Sub-study of the D2EFT Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03675815
• Other study ID #: D2EFT BodyComp
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 5, 2019
• Est. completion date: January 15, 2024

Study information

• Verified date: November 2022
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
India	Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site	Chennai
Malaysia	Univerity of Malaya Medical Centre	Kuala Lumpur
South Africa	Desmond Tutu HIV Foundation	Cape Town
South Africa	Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital	Soweto	Johannesburg
South Africa	Clinical HIV Research Unit, Helen Joseph Hospital	Westdene	Johannesburg
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre	Bangkok
Zimbabwe	University of Zimbabwe Clinical Research Centre	Harare

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Countries where clinical trial is conducted

India,  Malaysia,  South Africa,  Thailand,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean/median between-group change in serum biomarker concentrations	biomarkers to be determined	weeks 48 and 96
Primary	Mean/median between-group change in waist-to-hip ratio	umbilical waist and hip measures	at 48 weeks
Primary	Mean/median between-group change in total-to-HDL cholesterol ratio	total and HDL cholesterol plasma concentrations	at 48 weeks
Secondary	Mean/median between-group change in total-to-HDL cholesterol ratio	total and HDL cholesterol plasma concentrations	at 96 weeks
Secondary	Mean/median between-group change in waist-to-hip ratio	umbilical waist and hip measures	at 96 weeks
Secondary	Mean/median between-group change in body weight	body weight measurement	at week 48 and 96
Secondary	Mean/median between-group change in maximum umbilical and hip measures	umbilical waist and hip measures	at week 48 and 96
Secondary	Mean/median between-group change in fasting lipid parameters	total, HDL, and LDL cholesterol and triglyceride plasma concentrations	at weeks 48 and 96
Secondary	Mean/median between-group change in fasting glycaemic parameters	glucose, insulin, HbA1c concentrations	at weeks 48 and 96
Secondary	Mean/median between-group absolute change in limb fat assessed by DXA	absolute change from baseline in limb fat	week 48 and 96
Secondary	Mean/median between-group percentage change in limb fat assessed by DXA	percentage change from baseline in limb fat	week 48 and 96
Secondary	Mean/median between-group changes in regional body fat assessed by DXA	regional = limb fat and truncal fat	week 48 and 96
Secondary	Mean/median between-group changes in total body fat and lean tissue assessed by DXA	total body fat and total lean tissue	week 48 and 96
Secondary	Mean/median between-group changes in bone mineral content assessed by DXA	total bone mineral content	week 48 and 96
Secondary	Mean/median between-group change in Body Image questionnaire scores	NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires	weeks 48 and 96
Secondary	Proportion with Metabolic Syndrome	baseline prevalence and incidence at weeks 48 and 96	week 0, and week 48 and 96