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Completed

NCT Number: NCT03675815

Body Composition Sub-study of the D2EFT Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site, Chennai, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darunavir (DRV) 800 milligram (MG) Oral Tablet

Drug

800 milligrams (mg) orally once daily for 96 weeks

Other names: Prezista

Ritonavir 100 MG Oral Tablet

Drug

100 mg orally once daily for 96 weeks

Other names: Norvir, RTV

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

Other names: Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]

Dolutegravir 50 MG Oral Tablet

Drug

50 mg orally once daily for 96 weeks

Other names: Tivicay, DTG

TDF 300 MG Oral Tablet

Drug

300 mg orally once daily for 96 weeks

Other names: tenofovir disoproxil fumarate, Viread

3TC 300 MG Oral Tablet

Drug

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

Other names: lamivudine

FTC 200 MG Oral Cap

Drug

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

Other names: Emtriva, emtricitabine

Primary outcomes

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

    Time frame: at 48 weeks

    umbilical waist and hip measures

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

    Time frame: at 48 weeks

    total and HDL cholesterol plasma concentrations

Secondary outcomes

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

    Time frame: at 96 weeks

    total and HDL cholesterol plasma concentrations

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

    Time frame: at 96 weeks

    umbilical waist and hip measures

  3. Mean/median between-group change in body weight

    Time frame: at week 48 and 96

    body weight measurement

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

    Time frame: at week 48 and 96

    umbilical waist and hip measures

  5. Mean/median between-group change in fasting lipid parameters

    Time frame: at weeks 48 and 96

    total, HDL, and LDL cholesterol and triglyceride plasma concentrations

  6. Mean/median between-group change in fasting glycaemic parameters

    Time frame: at weeks 48 and 96

    glucose, insulin, HbA1c concentrations

  7. Mean/median between-group absolute change in limb fat assessed by DXA

    Time frame: week 48 and 96

    absolute change from baseline in limb fat

  8. Mean/median between-group percentage change in limb fat assessed by DXA

    Time frame: week 48 and 96

    percentage change from baseline in limb fat

  9. Mean/median between-group changes in regional body fat assessed by DXA

    Time frame: week 48 and 96

    regional = limb fat and truncal fat

  10. Mean/median between-group changes in total body fat and lean tissue assessed by DXA

    Time frame: week 48 and 96

    total body fat and total lean tissue

  11. Mean/median between-group changes in bone mineral content assessed by DXA

    Time frame: week 48 and 96

    total bone mineral content

  12. Mean/median between-group change in Body Image questionnaire scores

    Time frame: weeks 48 and 96

    NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires

  13. Proportion with Metabolic Syndrome

    Time frame: week 0, and week 48 and 96

    baseline prevalence and incidence at weeks 48 and 96

Other outcomes

  1. Mean/median between-group change in serum biomarker concentrations

    Time frame: weeks 48 and 96

    biomarkers to be determined

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2018
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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