Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2024-12-31

Brief Summary

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Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR).

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Detailed Description

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Conditions

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HIV-1-infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Switch from Etravirine to Doravirine

Switch from etravirine to Doravirine (Pifeltro) 100 mg each day

Group Type EXPERIMENTAL

Doravirine 100Mg Tab

Intervention Type DRUG

Switch from Etravirine to Doravirine

Interventions

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Doravirine 100Mg Tab

Switch from Etravirine to Doravirine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-1-infected subjects with age ≥18 years old.
* Desire of the patient to simplify their ART-regimen.
* Having plasma HIV-1 RNA \< 50 copies/mL during at least the previous 24 weeks.
* Currently receiving an ETR-containing regimen (unchanged during the previous 24 weeks).
* Documented pooled/historical genotype or GRT in pro-viral DNA must show the presence of 103N and/or 181C and/or 190A and/or 100I and/or 138K/A.

Exclusion Criteria

* Documented pooled/historical genotype or GRT in pro-viral DNA of any DOR-DRM (Mutations V106A, Y188L, and M230L, and combinations of V106A and L234I; V106A and F227L and L234I; and V106A and 190A and F227L).
* Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods, for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
* Active tuberculosis infection.
* Any clinical condition or therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No