Clinical trial NCT03675815: Body Composition Sub-study of the D2EFT Trial
Official title: Body Composition Sub-study of the D2EFT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2018-09-18
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean/median between-group change in waist-to-hip ratio
timeFrame: at 48 weeks
measure: Mean/median between-group change in total-to-HDL cholesterol ratio
timeFrame: at 48 weeks
Secondary outcomes:
measure: Mean/median between-group change in total-to-HDL cholesterol ratio
timeFrame: at 96 weeks
measure: Mean/median between-group change in waist-to-hip ratio
timeFrame: at 96 weeks
measure: Mean/median between-group change in body weight
timeFrame: at week 48 and 96
measure: Mean/median between-group change in maximum umbilical and hip measures
timeFrame: at week 48 and 96
measure: Mean/median between-group change in fasting lipid parameters
timeFrame: at weeks 48 and 96
measure: Mean/median between-group change in fasting glycaemic parameters
timeFrame: at weeks 48 and 96
measure: Mean/median between-group absolute change in limb fat assessed by DXA
timeFrame: week 48 and 96
measure: Mean/median between-group percentage change in limb fat assessed by DXA
timeFrame: week 48 and 96
measure: Mean/median between-group changes in regional body fat assessed by DXA
timeFrame: week 48 and 96
measure: Mean/median between-group changes in total body fat and lean tissue assessed by DXA
timeFrame: week 48 and 96
measure: Mean/median between-group changes in bone mineral content assessed by DXA
timeFrame: week 48 and 96
measure: Mean/median between-group change in Body Image questionnaire scores
timeFrame: weeks 48 and 96
measure: Proportion with Metabolic Syndrome
timeFrame: week 0, and week 48 and 96
Other outcomes:
measure: Mean/median between-group change in serum biomarker concentrations
timeFrame: weeks 48 and 96
Locations:
city: Chennai
country: India
facility: Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site
city: Kuala Lumpur
country: Malaysia
facility: Univerity of Malaya Medical Centre
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
state: Johannesburg
city: Westdene
country: South Africa
facility: Clinical HIV Research Unit, Helen Joseph Hospital
state: Johannesburg
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre
city: Harare
country: Zimbabwe
facility: University of Zimbabwe Clinical Research Centre
Study officials:
affiliation: The Kirby Institute, UNSW Sydney
name: Gail Matthews, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: