Clinical trial NCT05506605: Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: HIV
Doravirine
Etravirine
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with confirmed HIV viral load>50 copies/mL
timeFrame: at week 24
Secondary outcomes:
measure: Percentage of participants with HIV viral load>50 copies/mL
timeFrame: at week 12 and 48
measure: Percentage of participants with HIV viral load<50 copies/mL
timeFrame: at week 12, 24 and 48
measure: Changes in CD4, CD8 cell counts and ratio CD4/CD8
timeFrame: at 48 weeks
measure: Incidence of Treatment-Emergent adverse events and serious adverse events
timeFrame: at week 48
measure: AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR
timeFrame: at weeks 2 and 4
measure: Maximum concentrations (Cmax) of DRV/r and DRV/c with DOR
timeFrame: at weeks 2 and 4
measure: Concentrations at the end of the dosing interval (C24) of DRV/r and DRV/c with DOR
timeFrame: at weeks 2 and 4
measure: Elimination half-life (t1/2) of DRV/r and DRV/c with DOR
timeFrame: at weeks 2 and 4
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
References: