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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334551
• Other study ID #: Doravirine and HIV VT#59184
• Status: Recruiting
• Phase: Phase 4
• Start date: June 23, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2021
• Source: Clinique du Quartier Latin
• Contact: Ioannis vertzagias
• Phone: 5142853401
• Email: ivertzagias[@]cmql.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Doravirine
switches from etravirine to doravirine, in experienced HIV patients

Locations

Country	Name	City	State
Canada	Clinique Du Quartier Latin	Montreal	Quebec
Canada	Clinique Du Quartier Latin	Montreal	Quebec
Martinique	CHU Martinique	Fort-de-France	Fort De France

Sponsors (2)

Lead Sponsor	Collaborator
Clinique du Quartier Latin	Merck Frosst Canada Ltd.

Countries where clinical trial is conducted

Canada,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who maintain virologic control .	Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL.	24 weeks