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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2022-10-01

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

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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switch from etravirine to doravirine

switches to doravirine,

Group Type EXPERIMENTAL

Doravirine

Intervention Type DRUG

switches from etravirine to doravirine, in experienced HIV patients

Interventions

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Doravirine

switches from etravirine to doravirine, in experienced HIV patients

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No