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

• Status: Not yet recruiting
• Trial end date: 2024-10-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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.