Open Label, Randomized (1:1) Clinical Trial to Evaluate Switching From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE Study).

Be-OnE Study

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.

2017-02-06

2018-03-20

2020-07-31

Terminated

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatments\n\n1. Genvoya 150Mg-150Mg-200Mg-10Mg Tablet ( 1 pill every 24 hours)\n2. Dolutegravir 50 mg (1 pill every 24 hours) plus one Reverse Trascriptase Inhibitor (at label dose)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2024-02-09