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Status:

UNKNOWN

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

Lead Sponsor:

Clinique du Quartier Latin

Collaborating Sponsors:

Merck Frosst Canada Ltd.

Conditions:

HIV Infections

Eligibility:

All Genders

18-90 years

Phase:

PHASE4

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...

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 ...

Eligibility Criteria

Inclusion

  • \- 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

  • 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

Key Trial Info

Start Date :

June 23 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04334551

Start Date

June 23 2020

End Date

October 1 2022

Last Update

January 29 2021

Active Locations (3)

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Page 1 of 1 (3 locations)

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