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

NCT05506605 | Unknown Phase 4

• 1 other identifier: DoRSwitch.21
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV-1-infection

Keywords

HIV; Doravirine; Etravirine

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with confirmed HIV viral load>50 copies/mL

  Measured by blood HIV viral load

  at week 24

Secondary Outcomes (8)

• Percentage of participants with HIV viral load>50 copies/mL

  at week 12 and 48

• Percentage of participants with HIV viral load<50 copies/mL

  at week 12, 24 and 48

• Changes in CD4, CD8 cell counts and ratio CD4/CD8

  at 48 weeks

• Incidence of Treatment-Emergent adverse events and serious adverse events

  at week 48

• AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR

  at weeks 2 and 4

Study Arms (1)

Switch from Etravirine to Doravirine

EXPERIMENTAL

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

Drug: Doravirine 100Mg Tab

Interventions

Doravirine 100Mg Tab DRUG

Switch from Etravirine to Doravirine

Switch from Etravirine to Doravirine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

doravirine

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Coordinator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 18, 2022
• Study Start: December 12, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)