HIV infection MedDRA version: 20.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Genvoya¿ 150 mg/150mg/200mg/10mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Elvitegravir/cobicistat/emtricitabina/tenofovir alafenamide
CAS Number: 1392275-56-7
Current S
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Willing and able to provide informed consent 3. On a stable (at least 3 months) antiretroviral therapy with DTG 50 mg QD plus one RTI 4. HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Active AIDS-defining condition (except Kaposi’s sarcoma non requiring systemic chemotherapy) 2. Serious illness requiring systemic treatment and/or hospitalization 3. Current use of immunomodulant or immunosuppressive drugs 4. Need (or will likely need) of treatment with antacids 5. Use of drugs contraindicated with study drugs, according to technical sheets 6. Previous suboptimal therapies with NRTIs or presence of TAMs (type 1 or 2) in previous resistance tests (patients with the 184I/V mutation alone are allowed to enter the study) 7. Resistance or previous virological failure to InSTIs 8. Detectable HCV-RNA 9. Documented allergy to COBI or EVG or FTC or tenofovir. 10. Absolute neutrophil count (ANC) <500/µL 11. Haemoglobin <8.0 g/dL 12. Platelet count <50,000/µL 13. eGFR <30 mL/min/1.73m2 by CKD-EPI equation 14. Alanine aminotransferase (ALT) ¿5 times the upper limit of normal (ULN) 15. Presence of Child Pugh Class B or C liver cirrhosis. 16. Pregnancy or breastfeeding 17. Woman of childbearing potential who does not agree to adopt highly effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate Residual Viremia through 48 weeks in virologically suppressed patients randomized to continue treatment with Dolutegravir plus a single RTI or to switch to E/C/F/TAF.;Secondary Objective: Secondary Objectives 1. To investigate the occurrence of virological rebound above 50 HIV-RNA copies/mL; 2. To investigate changes in viral reservoir; 3. To investigate changes in the quality of life (QOL) and in adherence. Primary Endpoint 1. Proportion of subjects without RV through 48 weeks of follow-up. ;Primary end point(s): Proportion of subjects without Residual Viremia through 48 weeks of follow-up.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects without RV through 96 weeks of follow-up; 3. Percentage of time spent with RV through 48 and 96 weeks of follow-up; 4. Proportion of subjects with HIV-RNA <50 copies/mL (virological success) at week 48 and 96 window; 5. Changes from baseline in: 1. Glucose and lipid profile, 2. BMI, waist circumference, 3. alkaline phospatase, 4. creatinine, eGFR, proteinuria, albuminuria, 5. HIV-DNA in PBMCs, 6. CD4+ and CD8+ cell counts, 7. quality of life (QOL) and in adherence. ;Timepoint(s) of evaluation of this end point: Every secondary endpoints will be collected at 48 and 96 weeks as scheduled per protocol | — |
Countries
Italy
Contacts
Public ContactUfficio Protocolli Clinici
IRCCS Ospedale San Raffaele
Outcome results
None listed