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

NCT04334551 | Unknown Phase 4 DMC

• 1 other identifier: Doravirine and HIV VT#59184
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who maintain virologic control .

  Virologic control is defined by measurement of HIV-1 RNA \< 50 copies/mL.

  24 weeks

Study Arms (1)

switch from etravirine to doravirine

EXPERIMENTAL

switches to doravirine,

Drug: Doravirine

Interventions

Doravirine DRUG

switches from etravirine to doravirine, in experienced HIV patients

switch from etravirine to doravirine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique du Quartier Latin: lead
• Merck Frosst Canada Ltd.: collaborator

Study Sites (3)

Clinique Du Quartier Latin

Montreal, Quebec, H2L 4E9, Canada

NOT YET RECRUITING

Clinique Du Quartier Latin

Montreal, Quebec, H2L 4E9, Canada

RECRUITING

CHU Martinique

Fort-de-France, Fort de France, CS 90632, Martinique

NOT YET RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

doravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Ioannis vertzagias

CONTACT

5142853401; ivertzagias@cmql.ca

benoit trottier, MD

CONTACT

5142853401; bentrotte@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Benoit Trottier Principal Investigator

Model Details: 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 Record Dates

• First Submitted: March 23, 2020
• First Posted: April 6, 2020
• Study Start: June 23, 2020
• Primary Completion: July 14, 2022
• Study Completion: October 1, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); CA (2)