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Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

NCT03017872 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2023-04-18

No results posted yet for this study

Summary

D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.

Conditions

  • HIV Infections

Interventions

DRUG

NRTIs

In SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection. In D2N arm, NRTIs are predetermined.

DRUG

Dolutegravir

50mg tablet by mouth once daily for 96 weeks.

DRUG

Darunavir

800mg tablet by mouth once daily for 96 weeks.

DRUG

Ritonavir

100mg tablet by mouth once daily for 96 weeks.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • ViiV Healthcare

    collaborator INDUSTRY

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Gail Matthews, MD · Kirby Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-23
Primary Completion
2022-11-11
Completion
2023-10-31

Countries

  • Argentina
  • Brazil
  • Chile
  • Colombia
  • Guinea
  • India
  • Indonesia
  • Malaysia
  • Mali
  • Mexico
  • Nigeria
  • South Africa
  • Thailand
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03017872 on ClinicalTrials.gov