subject whith PHI never treated MedDRA version: 20.1 Level: PT Classification code 10000807 Term: Acute HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: TIVICAY - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE
Product Name: TIVICAY
Product Code: [J05AX12]
Pharmaceutical Form: Film-coated tablet
INN or Prop
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race. - Primary HIV Infection defined according to Fiebig’s classification. - Subjects must have given written informed consent and must be able to adhere to dose and visit schedules. - Female subjects of child-bearing potential must agree to use a medically accepted method of contraception. - Female subjects of child-bearing potential must have a negative serum beta-hCG pregnancy test at Screening, and a negative urine beta-HCG pregnancy test on Day 1 prior to dosing. A female, may be eligible to enter and participate in the study if she: a is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and = 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy; a. is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: • Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications; • Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); • Any intrauterine device (IUD) with published data showing that the expected failure rate is =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant. - Subjects with active opportunistic infection or malignancy. - Subjects positive for Hepatitis B at screening (HBsAg+), or anticipated need for Hepatitis C virus (HCV) therapy during the study. - Subjects with known liver cirrhosis. - Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal participation. - Subjects with allergy/sensitivity to drugs or its excipients. - History or presence of allergy to the study drugs or their components - Alanine aminotransferase (ALT) ¿5 times the upper limit of normal (ULN), OR ALT ¿3xULN and bilirubin ¿1.5xULN (with >35% direct bilirubin) - Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) - Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification - Subject has creatinine clearance of <70 mL/min via Cockroft-Gault method - Hepatic failure (Child-Plug grade C) - Use of not modifiable concomitant drugs: carbamazepine, fenitoine, fenobarbital, rifampicine, Hypericum perforatum, dofelitide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary end point will be the change in total HIV-DNA level from baseline to 48 weeks;Secondary Objective: • long-term virological efficacy; • safety; • viral reservoirs: HIVDNA in PBMC, anal brushing, nasal brushing and HIVRNA in cerebrospinal fluid (CSF) ; • pharmacokinetic (Ctrough) on plasma and PBMC, anal and nasal brushing and cerebrospinal fluid (CSF), lymph nodes and GALT; • genetic markers: HLA-A, HLA-B, HLA-C; • variation in immunological parameters; • variation in inflammation and immune-activation markers; • variation in T-cells, B-cells and DC-phenotypes; • variation of viral tropism. ;Primary end point(s): The primary end point will be the change in total HIV-DNA level from baseline to 48 weeks.;Timepoint(s) of evaluation of this end point: 48 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: necessary time period; week 12 and 48; week 48; week 48; week 12; settimane 12 e 48; indefinite; indefinite; week 12 and 48; week 12 and 48; week 48; indefinite; indefinite; week 12, 24 and 48;Secondary end point(s): • time to achieve undetectable viral load (HIV-1 RNA 1 at week 48;; • change in HIV-1 RNA at week 12 in CSF; • change in in nasal brushing HIV DNA at week 12 and 48 • change in anal brushing HIV DNA at weeks 12 and 48 ; - Correlazione della concentrazione dei farmaci (TAF, FTC, DRV/c, DTG) con la risposta virologica; • correlation of PBMC, CSF, lymph nodes, anal brushing, nasal brushing and GALT concentrations (TDF, FTC, DRV/c and DTG) with virological decay and persistent virus; • change from baseline in T cells subpopulation at week 12 and 48; • change from baseline in B cells population at week 12 and 48; • change from baseline in DC phenotype at week 12 and 48 ; • change from baseline in inflammation and immune-activation markers at week 12 and 48; • change from baseline in microbioma at week 48; • proportion of patients with AEs (clinical and laboratory), proportion of patients who discontinued and reasons for treatment discontinuation (e.g. due to AE/Loss of viral control/Death/Patient decision); - Proporzione di pazienti con gli stessi alleli HLA-A, HLA-B e HLA-C; • proportion of patients with HIV-1 RNA <50 copies/mL at week 12, 24 and week 48; | — |
Countries
Italy
Contacts
Public ContactClinical Operation
Kilimo srl
Outcome results
None listed