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

Open-label, Single-arm, Unicenter and Pilot Study of a Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance

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).

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Doravirine 100Mg Tab

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Switch from Etravirine to Doravirine; Switch from etravirine to Doravirine (Pifeltro) 100 mg each day	Drug: Doravirine 100Mg Tab; Switch from Etravirine to Doravirine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with confirmed HIV viral load>50 copies/mL	Measured by blood HIV viral load	at week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with HIV viral load>50 copies/mL	Measured by blood HIV viral load	at week 12 and 48
Percentage of participants with HIV viral load<50 copies/mL	Measured by blood HIV viral load	at week 12, 24 and 48
Changes in CD4, CD8 cell counts and ratio CD4/CD8	Measured by blood CD4, CD8 and CD/4/CD8 ratio	at 48 weeks
Incidence of Treatment-Emergent adverse events and serious adverse events	Measured by numer of AEs and SAEs related to the treatment	at week 48
AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR		at weeks 2 and 4
Maximum concentrations (Cmax) of DRV/r and DRV/c with DOR		at weeks 2 and 4
Concentrations at the end of the dosing interval (C24) of DRV/r and DRV/c with DOR		at weeks 2 and 4
Elimination half-life (t1/2) of DRV/r and DRV/c with DOR		at weeks 2 and 4

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Etravirine; Doravirine
• Other Study ID Numbers: DoRSwitch.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No