Pilot Study of a Switch strategy from Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001591-33-ES

Enrollment

Registered

2022-07-27

Start date

2022-10-06

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV) MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: PIFELTRO Pharmaceutical Form: Capsule INN or Proposed INN: Doravirine CAS Number: 1338225-97-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of a switch of Etravirine (ETR) to Doravirine (DOR) for maintenance of virologic suppression at 48 weeks (50 copies/mL;Timepoint(s) of evaluation of this end point: week 24	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Percentage of participants with VL>50 copies/mL and VL<50 copies/mL 2. Changes in CD4, CD8 cell counts and ratio CD4/CD8 3. To assess safety and tolerability, measured by the number de AEs and SAEs related with the treatment 4. To determine the pharmacokinetic interaction between DRV/r and DRV/c with DOR at weeks 2 and 4;Timepoint(s) of evaluation of this end point: 1. at week 12, 24 and 48 2. at 48 weeks 3. at 48 weeks 4. at weeks 2 and 4	—

Measure

Time frame

Secondary end point(s): 1. Percentage of participants with VL>50 copies/mL and VL<50 copies/mL 2. Changes in CD4, CD8 cell counts and ratio CD4/CD8 3. To assess safety and tolerability, measured by the number de AEs and SAEs related with the treatment 4. To determine the pharmacokinetic interaction between DRV/r and DRV/c with DOR at weeks 2 and 4;Timepoint(s) of evaluation of this end point: 1. at week 12, 24 and 48 2. at 48 weeks 3. at 48 weeks 4. at weeks 2 and 4

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Countries

Spain

Contacts

Public ContactAnna Cruceta

CTU clínic

acruceta@recerca.clinic.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026