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

Sponsor

Clinique du Quartier Latin (Other)

Overall Status

Recruiting

CT.gov ID

NCT04334551

Collaborator

Merck Frosst Canada Ltd. (Industry)

Enrollment

Locations

Arm

27.3

Anticipated Duration (Months)

13.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 resistanceA 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

Actual Study Start Date :

Jun 23, 2020

Anticipated Primary Completion Date :

Jul 14, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: switch from etravirine to doravirine

switches to doravirine,

Drug: Doravirine

switches from etravirine to doravirine, in experienced HIV patients

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Du Quartier Latin	Montreal	Quebec	Canada	H2L 4E9
2	Clinique Du Quartier Latin	Montreal	Quebec	Canada	H2L 4E9
3	CHU Martinique	Fort-de-France	Fort De France	Martinique	CS 90632

Sponsors and Collaborators

Clinique du Quartier Latin
Merck Frosst Canada Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 6, 2020

Last Update Posted:

Jan 29, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jan 29, 2021