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

Fundacion Clinic per a la Recerca Biomédica

Status and phase

Active, not recruiting

Phase 4

Conditions

HIV-1-infection

Treatments

Drug: Doravirine 100Mg Tab

Study type

Interventional

Funder types

Other

Identifiers

NCT05506605

DoRSwitch.21

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.