HIV-1 MedDRA version: 20.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Rezolsta
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DARUNAVIR ETHANOLATE
CAS Number: 635728-49-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
FUNDACIÓ LLUITA CONTRA LA SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected patients (=18 years). 2. Confirmed plasma HIV-1 RNA levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with any DRM associated to INSTI (i.e. T66I, 74M, E92Q, T97A, F121Y, E138A/K, G140A/S, Y143R/H/C, S147G, Q148H/K/R, N155H AND R263K) in historical genotyping tests. 2. Patients with any evidence of previous virologic failure to INSTI-based regimens (with or without drm in the integrase). 3. Patients who have experienced previous uncontrolled interruptions of INSTI-based regimens. 4. Patients who have archived DRM conferring a low – or higher - level of resistance to DRV/cobi (>15 points from Stanford dB score) . 5. Patients with unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones) 6. Patients with severe heaptic impairment (class C) according to the Child-Pugh classification 7. Patients with alanine aminotransferase (ALT) = 5 times upper normal limit (ULN) or ALT = 3 times ULN and bilirubin = 1.5 times ULN. 8. Patients with hepatitis C co-infection that would require therapy during the study. 9. Patients with hepatitis B surface antigen (HBsAg) positive. 10. Known allergy to the study drugs or their components. 11. Current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study. 12. Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the efficacy of DTG plus DRV/cobi bitherapy as a once-daily simplification strategy versus maintenance of the current antiretroviral regimen in maintaining virological suppression (RNA HIV-1 < 50 copies/mL) at Week 48 (by Time to Loss of Virological Response, TLOVR) in well suppressed and highly experienced patients harboring archived DRM against at least two antiretroviral classes.;Secondary Objective: • To evaluate and compare the safety and tolerability of DTG plus DRV/cobi biotherapy as a once-daily simplification strategy versus maintenance of the current antiretroviral regimen in well suppressed and highly experienced patients harboring archived DRM against at least two antiretroviral classes. • To evaluate the development of new resistance mutations in highly experienced subjects harboring archived DRM who experience virologic failure after switching to DTG plus DRV/cobi. • To evaluate the durability of efficacy at Week 24 in maintaining HIV-1 RNA < 50 copies/mL using TLOVR. • To characterize the plasmatic concentrations of DTG and DRV/cobi during the study. • To evaluate and compare the costs associated with DTG plus DRV/cobi versus maintenance of the current antiretroviral regimen.;Primary end point(s): HIV-1 RNA < 50 copies/mL at 48 weeks using a Time to Loss of Virological Response (TLOVR).;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients developing ART-associated adverse events leading to treatment discontinuation. • Changes in CD4+ cell count, hematologic and biochemical parameters during the follow-up. • Emergence of new mutations in HIV-1 protease and integrase • HIV-1 RNA< 50 copies/mL at 24 weeks (by TLOVR). • HIV-1 RNA < 50 copies/mL at 24 and 48 weeks using the FDA snapshot analysis (sensitivity analysis). • Description of plasmatic trough levels of DTG and DRV/cobi in the experimental group at Weeks 4, and in those patients experiencing virological failure. • Costs associated with DTG plus DRV/cobi bitherapy and current ART.;Timepoint(s) of evaluation of this end point: 1-2-3-7: throughout the study 4. Week 24 5. Week 24 and 48 6. Week 4 for experimental group and throughout the study for those patients experiencing virological failure | — |
Countries
Spain
Contacts
Public ContactCRA
Fundació Lluita contra la SIDA
Outcome results
None listed