Overview

Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE)

Status:
Unknown status
Trial end date:
2020-07-31
Target enrollment:
0
Participant gender:
All
Summary
Research hypothesis: Switching from dual regimens based on dolutegravir plus a RTI to a single tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), lowers the exposure to Residual Viremia (and hence the risk of viral rebound), without increasing treatment toxicity.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ospedale San Raffaele
Collaborator:
Gilead Sciences
Treatments:
Cobicistat
Dolutegravir
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine
Reverse Transcriptase Inhibitors
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 <50 copies/mL since at least 6 months

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) more than 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.