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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Doravirine
Sponsored by
Clinique du Quartier Latin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Du Quartier Latin
  • Clinique Du Quartier LatinRecruiting
  • CHU Martinique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

switch from etravirine to doravirine

Arm Description

switches to doravirine,

Outcomes

Primary Outcome Measures

Percentage of subjects who maintain virologic control .
Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
January 26, 2021
Sponsor
Clinique du Quartier Latin
Collaborators
Merck Frosst Canada Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04334551
Brief Title
HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
July 14, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique du Quartier Latin
Collaborators
Merck Frosst Canada Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
switch from etravirine to doravirine
Arm Type
Experimental
Arm Description
switches to doravirine,
Intervention Type
Drug
Intervention Name(s)
Doravirine
Intervention Description
switches from etravirine to doravirine, in experienced HIV patients
Primary Outcome Measure Information:
Title
Percentage of subjects who maintain virologic control .
Description
Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ioannis vertzagias
Phone
5142853401
Email
ivertzagias@cmql.ca
First Name & Middle Initial & Last Name or Official Title & Degree
benoit trottier, MD
Phone
5142853401
Email
bentrotte@gmail.com
Facility Information:
Facility Name
Clinique Du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis vertzagias
Phone
5142853401
Email
ivertzagias@cmql.ca
First Name & Middle Initial & Last Name & Degree
Benoit Trottier, MD
Facility Name
Clinique Du Quartier Latin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis vertzagias
Phone
5142853401
Email
ivertzagias@cmql.ca
First Name & Middle Initial & Last Name & Degree
Benoit Trottier, MD
Facility Name
CHU Martinique
City
Fort-de-France
State/Province
Fort De France
ZIP/Postal Code
CS 90632
Country
Martinique
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Cabie
Phone
0596 55 23 73
Email
Andre.CABIE@chu-martinique.fr
First Name & Middle Initial & Last Name & Degree
Lise Cuzin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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