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

Phase 4

• Conditions: HIV Infections
• Interventions: Drug: Doravirine

• Registration Number: NCT04334551
• Lead Sponsor: Clinique du Quartier Latin

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

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 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 Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2020-06-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29
• Primary Completion: 2022-07-14
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
switch from etravirine to doravirine	Doravirine	switches to doravirine,

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who maintain virologic control .	24 weeks	Virologic control is defined by measurement of HIV-1 RNA \< 50 copies/mL.

Trial Locations

Locations (2)

CHU Martinique; 🇲🇶 Fort-de-France, Fort De France, Martinique

Clinique Du Quartier Latin; 🇨🇦 Montreal, Quebec, Canada