Clinical trial NCT04334551: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Clinique du Quartier Latin
Sponsor class: NETWORK
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2020-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of subjects who maintain virologic control .
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Clinique Du Quartier Latin
state: Quebec
city: Fort-de-France
country: Martinique
facility: CHU Martinique
state: Fort De France
Study officials:
References: