Body Composition Sub-study of the D2EFT Trial

Kirby Institute

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Ritonavir 100 MG Oral Tablet; Drug: Dolutegravir 50 MG Oral Tablet; Drug: N(t)RTIs; Drug: FTC 200 MG Oral Cap; Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet; Drug: TDF 300 MG Oral Tablet; Drug: 3TC 300 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03675815

D2EFT BodyComp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Standard of care

Active Comparator group

Description:

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

Treatment:

Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet

Drug: N(t)RTIs

Drug: Ritonavir 100 MG Oral Tablet

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

Experimental group

Description:

dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd

Treatment:

Drug: 3TC 300 MG Oral Tablet

Drug: TDF 300 MG Oral Tablet

Drug: FTC 200 MG Oral Cap

Drug: Dolutegravir 50 MG Oral Tablet

Dolutegravir + darunavir

Experimental group

Description:

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

Treatment:

Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet

Drug: Dolutegravir 50 MG Oral Tablet

Drug: Ritonavir 100 MG Oral Tablet