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

Phase 4

Active, not recruiting

• Conditions: HIV-1-infection
• Interventions: Drug: Doravirine 100Mg Tab

• Registration Number: NCT05506605
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-18
• Study Start: 2022-12-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Switch from Etravirine to Doravirine	Doravirine 100Mg Tab	Switch from etravirine to Doravirine (Pifeltro) 100 mg each day

Primary Outcome Measures

Name	Time	Method
Percentage of participants with confirmed HIV viral load>50 copies/mL	at week 24	Measured by blood HIV viral load

Secondary Outcome Measures

Name	Time	Method
Changes in CD4, CD8 cell counts and ratio CD4/CD8	at 48 weeks	Measured by blood CD4, CD8 and CD/4/CD8 ratio
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
Percentage of participants with HIV viral load>50 copies/mL	at week 12 and 48	Measured by blood HIV viral load
Percentage of participants with HIV viral load<50 copies/mL	at week 12, 24 and 48	Measured by blood HIV viral load
Incidence of Treatment-Emergent adverse events and serious adverse events	at week 48	Measured by numer of AEs and SAEs related to the treatment
AUC during the dose interval (AUC0-24) 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

Trial Locations

Locations (1)

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain