Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334551
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Benoit Trottier, Clinique du Quartier Latin

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


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Doravirine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Etravirine

Arm Intervention/treatment
Experimental: switch from etravirine to doravirine
switches to doravirine,
Drug: Doravirine
switches from etravirine to doravirine, in experienced HIV patients




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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334551


Contacts
Layout table for location contacts
Contact: Ioannis vertzagias 5142853401 ivertzagias@cmql.ca
Contact: benoit trottier, MD 5142853401 bentrotte@gmail.com

Locations
Layout table for location information
Canada, Quebec
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.
Layout table for additonal information
Responsible Party: Benoit Trottier, Dr Benoit Trottier Principal Investigator, Clinique du Quartier Latin
ClinicalTrials.gov Identifier: NCT04334551    
Other Study ID Numbers: Doravirine and HIV VT#59184
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases