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Body Composition Sub-study of the D2EFT Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675815
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Darunavir 800 MG Oral Tablet Drug: Ritonavir 100 MG Oral Tablet Drug: N(t)RTIs Drug: Dolutegravir 50 MG Oral Tablet Drug: TDF 300 MG Oral Tablet Drug: 3TC 300 MG Oral Tablet Drug: FTC 200 MG Oral Cap Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body Composition Sub-study of the D2EFT Trial
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of care
darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd
Drug: Darunavir 800 MG Oral Tablet
800 milligrams (mg) orally once daily for 96 weeks
Other Name: DRV, Prezista

Drug: Ritonavir 100 MG Oral Tablet
100 mg orally once daily for 96 weeks
Other Name: Norvir, RTV

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
Other Name: Nucleoside/nucleotide reverse transcriptase inhibitors

Experimental: Dolutegravir + TDF + either 3TC or FTC
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
50 mg orally once daily for 96 weeks
Other Name: Tivicay, DTG

Drug: TDF 300 MG Oral Tablet
300 mg orally once daily for 96 weeks
Other Name: tenofovir disoproxil fumarate, Viread

Drug: 3TC 300 MG Oral Tablet
300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
Other Name: lamivudine

Drug: FTC 200 MG Oral Cap
200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
Other Name: Emtriva, emtricitabine

Experimental: Dolutegravir + darunavir
dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd
Drug: Darunavir 800 MG Oral Tablet
800 milligrams (mg) orally once daily for 96 weeks
Other Name: DRV, Prezista

Drug: Ritonavir 100 MG Oral Tablet
100 mg orally once daily for 96 weeks
Other Name: Norvir, RTV

Drug: Dolutegravir 50 MG Oral Tablet
50 mg orally once daily for 96 weeks
Other Name: Tivicay, DTG




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Mean/median between-group change in serum biomarker concentrations [ Time Frame: weeks 48 and 96 ]
    biomarkers to be determined



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675815


Contacts
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Contact: Dianne Carey, PhD +61 2 9385 0908 dcarey@kirby.unsw.edu.au

Locations
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Malaysia
Univerity of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Contact: Margaret CH Tan    +60379492622    margarettan455@gmail.com   
Principal Investigator: Iskandar S Raja Azwa, MBChB         
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Mark Polizzotto, MD The Kirby Institute, UNSW Sydney
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT03675815    
Other Study ID Numbers: D2EFT BodyComp
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
Tenofovir
Lamivudine
Emtricitabine
Dolutegravir
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors