Trial | NCT04334551  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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
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 Started
Jun 23
2020
Primary Completion
Jul 14
2022
Anticipated
Study Completion
Oct 01
2022
Anticipated
Last Update
Jan 29
2021

Drug Doravirine

switches from etravirine to doravirine, in experienced HIV patients

switch from etravirine to doravirine Experimental

switches to doravirine,

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
No Results Posted