HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

January 26, 2021 updated by: Benoit Trottier, Clinique du Quartier Latin

A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of Switches From Etravirine to Doravirine, in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.

The study will be performed only on two sites

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4E9
        • Not yet recruiting
        • Clinique Du Quartier Latin
        • Contact:
        • Principal Investigator:
          • Benoit Trottier, MD
      • Montreal, Quebec, Canada, H2L 4E9
        • Recruiting
        • Clinique Du Quartier Latin
        • Contact:
        • Principal Investigator:
          • Benoit Trottier, MD
  • Martinique
    • Fort De France
      • Fort-de-France, Fort De France, Martinique, CS 90632
        • Not yet recruiting
        • CHU Martinique
        • Contact:
        • Principal Investigator:
          • Lise Cuzin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Adult (18 Y.O. or more) women and men infected with HIV.

  • Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
  • Virologically controlled (HIV-1 RNA < 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
  • Presence of at least one major NNRTI mutation.
  • No limitation on the number of previous regimens.
  • HCV and HBV-infected patients are allowed

Exclusion Criteria:

High level of resistance to doravirine according to historical resistance tests.

  • Level of resistance to doravirine superior to that of etravirine
  • Opportunistic or serious active infection or disease
  • Active and untreated malignancy.
  • Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
  • Pregnancy.
  • Active treatment for hepatitis C is forbidden at entry but will be allowed after 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: switch from etravirine to doravirine
switches to doravirine,
Drug: Doravirine
switches from etravirine to doravirine, in experienced HIV patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects who maintain virologic control .
Time Frame: 24 weeks
Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique du Quartier Latin

Collaborators

Merck Frosst Canada Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 23, 2020

Primary Completion (ANTICIPATED)

July 14, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (ACTUAL)

April 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doravirine and HIV VT#59184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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