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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Doravirine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: switch from etravirine to doravirine<br>switches to doravirine, | Drug: Doravirine<br>* switches from etravirine to doravirine, in experienced HIV patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who maintain virologic control . | Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL. | 24 weeks |