Body Composition Sub-study of the D2EFT Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2024-01-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care

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

Group Type ACTIVE_COMPARATOR

Darunavir (DRV) 800 milligram (MG) Oral Tablet

Intervention Type DRUG

800 milligrams (mg) orally once daily for 96 weeks

Ritonavir 100 MG Oral Tablet

Intervention Type DRUG

100 mg orally once daily for 96 weeks

N(t)RTIs

Intervention Type 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

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

Group Type EXPERIMENTAL

Dolutegravir 50 MG Oral Tablet

Intervention Type DRUG

50 mg orally once daily for 96 weeks

TDF 300 MG Oral Tablet

Intervention Type DRUG

300 mg orally once daily for 96 weeks

3TC 300 MG Oral Tablet

Intervention Type DRUG

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

FTC 200 MG Oral Cap

Intervention Type DRUG

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

Dolutegravir + darunavir

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

Group Type EXPERIMENTAL

Darunavir (DRV) 800 milligram (MG) Oral Tablet

Intervention Type DRUG

800 milligrams (mg) orally once daily for 96 weeks

Ritonavir 100 MG Oral Tablet

Intervention Type DRUG

100 mg orally once daily for 96 weeks

Dolutegravir 50 MG Oral Tablet

Intervention Type DRUG

50 mg orally once daily for 96 weeks

Interventions

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Darunavir (DRV) 800 milligram (MG) Oral Tablet

800 milligrams (mg) orally once daily for 96 weeks

Intervention Type DRUG

Ritonavir 100 MG Oral Tablet

100 mg orally once daily for 96 weeks

Intervention Type 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

Intervention Type DRUG

Dolutegravir 50 MG Oral Tablet

50 mg orally once daily for 96 weeks

Intervention Type DRUG

TDF 300 MG Oral Tablet

300 mg orally once daily for 96 weeks

Intervention Type DRUG

3TC 300 MG Oral Tablet

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

Intervention Type DRUG

FTC 200 MG Oral Cap

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

Intervention Type DRUG

Other Intervention Names

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Prezista Norvir, RTV Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs] Tivicay, DTG tenofovir disoproxil fumarate, Viread lamivudine Emtriva, emtricitabine

Eligibility Criteria

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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