HIV infection MedDRA version: 20.0 Level: LLT Classification code 10020441 Term: Human immunodeficiency virus infection, unspecified System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Biktarvy
Product Name: Biktarvy
Product Code: [-]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bictegravir
CAS Number: 1611493-60-7
Current Sponsor code: -
Other descriptiv
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years - Stable treatment with EFV/TDF/FTC either QD or ATAD for at least 24 weeks before the screening -Virological suppression (HVRNA 50 ml/min - Women of childbearing potential must accept the use of one of the following contraceptive methods, from the screening for the duration of the study: Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal); progestagogenic hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable); intrauterine devices d; intrauterine devices with hormonal release system; bilateral tubal ligation; partner's vasectomy; sexual abstinence (hetero). -Men must agree to specified highly effective method of contraception during heterosexual intercourse or practice sexual abstinence from first dose throughout the study period - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Women who are pregnant or breastfeeding - HCV co-infection - Severe hepatic impairment - Known hypersensitivity to the study drug, the metabolites or formulation excipients - Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness - Ongoing malignancy (including untreated carcinoma in-situ) other than basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. - Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior the screening. - Receipt of immunosuppressive medications or immune-modulators within the past 6 months. - Use of pshycoactive substances which can interfere with patients adherence to the prescribed regimen - Subjects who do not guarantee an appropriate adherence to the study procedures, according to the investigator’s opinion - Enrollement in other clinical trials or pharmacological treatment with sperimental drug within the past 30 days. - Inability to express informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of switching from EFV/TDF/FTC either QD and on alternate days (ATAD) to BIC/TAF/FTC 48 weeks after switch in total population and comparing patients switching from EFV/TDF/FTC QD vs ATAD.;Secondary Objective: To evaluate, in total population, the following parameters: •safety •change in immunological recovery compared to baseline (BL) •change in lipid profile compared to BL •change in neurocognitive performance compared to BL Comparing patients switching from EFV/TDF/FTC QD vs ATAD. To evaluate in 3 subgroups (80 patients each) the following substudies: • 1st subgroup: to evaluate adherence and quality of life (self-reported questionnaires) (80 patients:40 patients switching from EFV/TDF/FTC QD and 40 switching from EFV/TDF/FTC ATAD) • 2nd subgroup: to evaluate bictegravir pharmakocinetic (80 patients) • 3rd subgroup: to evaluate the change of renal function, bone mineral density and bone turn-over markers from baseline (80 patients:40 patients switching from EFV/TDF/FTC QD and 40 switching from EFV/TDF/FTC ATAD).;Primary end point(s): • Number of patients with HIV RNA <50 copies / mL at week 24 (FDA snapshot analysis);Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of patients with viral rebound (HIV-RNA> 50 cp / mL in two consecutive samples); • Number of patients who discontinue treatment for any cause; • Number of patients discontinuing toxicity treatment; • WHO 3-4 degree of toxicity at any time; • Changes from baseline in the number of CD4 T-cells in peripheral blood (absolute number and%) at each visit; • Changes to the eGFR baseline (at any time); • Changes to the baseline of the lipid profile (total cholesterol, HDL and LDL, triglycerides, total cholesterol / HDL and LDL / HDL ratio) at each visit; • Changes to the baseline of neurocognitive functions (neurocognitive assessment NPZ-12) at week 48 and in patients with neuropsychiatric symptoms (self-reported neuropsychiatric symptom questionnaire, Pittsburg Sleep Quality Index, Beck Depression Inventory, Beck Anxiety Inventory) at week 48.;Timepoint(s) of evaluation of this end point: • At each visit -> Number of patients presenting with viral rebound; • At each visit -> Number of patients who discontinue treatment for any reason; • At each visit -> Number of patients discontinuing toxicity treatment; • At each visit -> WHO 3-4 degree of toxicity at any time; • At each visit -> Changes from baseline in the number of CD4 T-cells in peripheral blood; • At any time -> Changes to the eGFR baseline; • At each visit -> Changes to the baseline of the lipid profile at each visit; • Week 48 -> Changes to the baseline of neurocognitive functions and in patients with neuropsychiatric symptoms. | — |
Countries
Italy
Contacts
Public ContactUOC Immunodeficienze Virali
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Outcome results
None listed