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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Doravirine 100Mg Tab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Switch from Etravirine to Doravirine<br>Switch from etravirine to Doravirine (Pifeltro) 100 mg each day | Drug: Doravirine 100Mg Tab<br>* Switch from Etravirine to Doravirine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with confirmed HIV viral load>50 copies/mL | Measured by blood HIV viral load | at week 24 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Doravirine, Etravirine