Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch from Etravirine to Doravirine | Experimental | Switch from etravirine to Doravirine (Pifeltro) 100 mg each day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine 100Mg Tab | Drug | Switch from Etravirine to Doravirine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with confirmed HIV viral load>50 copies/mL | Measured by blood HIV viral load | at week 24 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000592662 | doravirine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |