Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified April 2020 by Benoit Trottier, Clinique du Quartier Latin

Sponsor
Clinique du Quartier Latin

Collaborator
Merck Frosst Canada Ltd.

Information provided by (Responsible Party)
Benoit Trottier, Clinique du Quartier Latin

ClinicalTrials.gov Identifier
NCT04334551

First received: March 23, 2020
Last updated: April 2, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : Doravirine
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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

Further study details as provided by Benoit Trottier, Clinique du Quartier Latin:

Primary Outcome Measures

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

Estimated Enrollment: 40
Study Start Date: May 1, 2020
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: switch from etravirine to doravirine
switches to doravirine,
Drug: Doravirine

switches from etravirine to doravirine, in experienced HIV patients

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 90 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04334551

Contacts

Contact:   Ioannis vertzagias 5142853401 ivertzagias@cmql.ca
Contact:   benoit trottier, MD 5142853401 bentrotte@gmail.com

Locations

Canada
Clinique Du Quartier Latin
Montreal, Quebec, Canada, H2L 4E9
Contact: Ioannis vertzagias    5142853401    ivertzagias@cmql.ca
Principal Investigator: Benoit Trottier, MD
Martinique
CHU Martinique
Fort-de-France, Fort De France, Martinique, CS 90632
Contact: André Cabie    0596 55 23 73    Andre.CABIE@chu-martinique.fr
Principal Investigator: Lise Cuzin, MD

Sponsors and Collaborators

Clinique du Quartier Latin
Merck Frosst Canada Ltd.
More Information

More Information


Responsible Party: Benoit Trottier, Dr Benoit Trottier Principal Investigator, Clinique du Quartier Latin  
ClinicalTrials.gov Identifier: NCT04334551   History of Changes  
Other Study ID Numbers: Doravirine and HIV VT#59184  
Study First Received: March 23, 2020  
Last Updated: April 2, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.