Recruiting

Etravirine & Doravirine

Sponsor:

Clinique du Quartier Latin

Code:

NCT04334551

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Doravirine

Study Details

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

Conditions

HIV Infections

Study ID

NCT04334551

Start date

Jun 23, 2020

Status verified date

Jan, 2021

Completion date

Oct 1, 2022

Anticipated

Primary completion date

Jul 14, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: switch from etravirine to doravirine

switches to doravirine,

Interventions

Doravirine

switches from etravirine to doravirine, in experienced HIV patients

Primary outcome measure

  • Percentage of subjects who maintain virologic control . [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Ioannis vertzagias

5142853401ivertzagias@cmql.ca

benoit trottier, MD

5142853401bentrotte@gmail.com

Locations

Clinique Du Quartier Latin

Recruiting

Montreal, Quebec, Canada, H2L 4E9

Contacts

Ioannis vertzagias

5142853401ivertzagias@cmql.ca

Principal Investigator:

Benoit Trottier, MD

More Information

Sponsor

Clinique du Quartier Latin

Last update posted

Jan 29, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clinique du Quartier Latin on 2021-01-29.