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: -
Concentration un
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 years; 2. Newly diagnosed with HIV-1 infection within 7 days before the enrolment with either: a) Confirmed or suspected AIDS defining event at screening (see appendix xx for AIDS defining conditions) or; b) Patients with CD4 cell count =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • Pregnant/breastfeeding women, or women who are willing to become pregnant or to breastfeed during study; • Impaired renal function defined as CrCl below 30 mL/min according to the CKD-EPI formula; • Severe hepatic impairment defined as Child-Pugh Class C; • Pulmonary or extrapulmonary active tuberculosis or expected treatment requiring Rifampicin or Rifabutin • Meningeal or disseminated cryptococcosis; • Known hypersensitivity to the study drug, the metabolites or formulation excipients; • Patients not able to subscribe informed consent; • Using any concomitant therapy disallowed as per product labelling for the study drugs. • Systemic cancer chemotherapy within 30 days prior to the study entry with the exclusion of Kaposi’s sarcoma and lymphomas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and feasibility of a rapid ART starting strategy (within 7 days from HIV diagnosis) based on B/F/TAF as initial regimen in HIV-infected naïve individuals presentating with an advanced HIV disease;Secondary Objective: •pure virologic response •virologic response determined by ultrasensitive HIV-1 RNA method •evolution of HIV-DNA in PBMC •emergent drug resistance-associated mutations in participants with protocol-defined virological failure •determination of viral co-recettorial tropism at screening •change in immunological competence from baseline •change in immune activation and inflammation from baseline •change in renal function from baseline •change in neurocognitive performance and neuropsychiatric status from baseline, excluding patients with neurological involvement from HIV infection or CNS opportunistic infections •safety and drug-drug interactions •changes of Self- reported adherence and level of therapy satisfaction •changes in PROs at BL, week 24 and week 48 (quaily of life assessment), Columbia-suicide severity rating scale, Pittsburgh sleep quality index •TDM of Bictegravir;Primary end point(s): Time-to-clinical or virologic failure, as the first occurrence of any of the following components: Virological reasons A) failure to achieve virologic response defined as either: 1. HIV-1 RNA reduction = 200 copies/mL at or after 24 weeks (confirmed within 2 weeks) 3. HIV-1 RNA >= 50 copies /ml at W48 (confirmed within 2 weeks) B) viral rebound, which is subsequently defined as either: 1. rebound of HIV-1 RNA to >200 copies/mL after having achieved HIV-1 RNA 1 log 10 copies/mL from nadir value, for patients whose viral load has never been suppressed below 50 copies/mL (confirmed within 2 weeks) Clinical reasons A) Change of any component of the initial randomized regimen before week 48 because of toxicity or unmanageable drug-drug interactions or IRIS B) Death due to any cause C) Any new or recurrent AIDS defining ev | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time-to-pure virologic failure, as the first occurrence of any of the following components: 1. failure to achieve virologic response defined as either: - HIV-1 RNA reduction =200 copies/mL at or after 24 weeks (confirmed within 2 weeks) - HIV-1 RNA > = 50 copies /ml at any time after W48 (confirmed within 2 weeks) • Percentage of subjects with HIV-1 RNA 5 copies/mL at week 48 by ultrasensitive assay • Change in total viral HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) at baseline and at w48 • Assessment of viral co-receptor tropism at screening. If not performed at screening, will be performed at baseline. • Proportion of participants developing resistance-conferring mutations (integrase and reverse transcriptase) by genotypic resistance test (GRT) by standard SS technique at screening and ai PDVF. • Proportion of viral minority variants (>1% prevalence) harboring resistance associated mutations in reverse transcriptase and integrase by NGS will be at the time of PDVF . • Change from baseline in CD4+ T-cells count (absolute and %) and CD4/CD8 ratio in the peripheral blood at any visit • Percentage of activated T-cell lymphocyte subset (%CD38+DR+) and monocyte subset (%CD14+CD16+ and %CD14(dim)CD16+), at baseline, week 24 and 48 • Absolute and percentage values of inflammation and pro-coagulation markers (soluble CD14, soluble CD163, IL-6, D-Dimer, high-sensitivity C-Reactive Protein) at baseline and at week 24 and 48 • Change in urinary tubular damage markers (alpha-1-microglobulin, beta-2-microglobulin) and albumin-creatinine ratio (ACR), at baseline, 24 and 48 weeks. • Change in neurocognitive performance • Proportion of patients discontinuing • WHO grade 3-4 toxicity at any time • Changes of Self- reported adherence and level of therapy satisfaction (HIVTSQ) at week 12, week 24 and week 48 • Changes in PROs at BL, week 24 and week 48 (quaily of life assessment (SF-12; EQ5D) [Appendix F1, F2], Columbia-suicide severity r | — |
Countries
Italy
Contacts
Public ContactImmunodeficienze Virali
INMI Lazzaro Spallanzani IRCCS
Outcome results
None listed