HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
Verified April 2020 by Benoit Trottier, Clinique du Quartier Latin
Clinique du Quartier Latin
Merck Frosst Canada Ltd.
Information provided by (Responsible Party)
Benoit Trottier, Clinique du Quartier Latin
First received: March 23, 2020
Last updated: April 2, 2020
Last Verified: April 2020
History of Changes
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
Drug : Doravirine
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.
|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)|
switch from etravirine to doravirine
switches to doravirine,
switches from etravirine to doravirine, in experienced HIV patients
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
|Ages Eligible for Study:||18 Years to 90 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- Active treatment for hepatitis C is forbidden at entry but will be allowed after 3
High level of resistance to doravirine according to historical resistance tests.
Contacts and LocationsChoosing 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
|Contact: Ioannis email@example.com|
|Contact: benoit trottier, MDfirstname.lastname@example.org|
Locations Show More
|Clinique Du Quartier Latin|
|Montreal, Quebec, Canada, H2L 4E9|
Contact: Ioannis vertzagias  5142853401  email@example.com
Principal Investigator: Benoit Trottier, MD
|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 CollaboratorsClinique du Quartier Latin
Merck Frosst Canada Ltd.
|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:
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.