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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05506605
• Other study ID #: DoRSwitch.21
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 12, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Doravirine 100Mg Tab
Switch from Etravirine to Doravirine

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

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