patients affected by HIV with negative viremia values MedDRA version: 8.1 Level: LLT Classification code 10000807 Term: Acute HIV infection
Conditions
Interventions
Trade Name: APTIVUS
Pharmaceutical Form: Capsule, soft
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: NORVIR
Pharmaceutical Form: Capsule, soft
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects between 18 and 65 years of age inclusive; Subject has given written informed consent HIV-1 infected patients; HIV-1 strains resistant to more than 1 PIs or 2 PIs failure; Two active drugs as optimised background regimen based on Virtual Phenotype testing, including investigational drugs. TPV phenotypic cut-off 1.2xWT IC50 Virtual Phenotype ; Any Viral Load; Any CD4 counts cell; Acceptable screening laboratory values that indicate adequate baseline organ function ALT 8804;3 x ULN and AST 8804;2.5 x ULN 8804; DAIDS Grade 1 ; Patients with chronic hepatitis B or C infection but no more than DAIDS grade 2 ALT 3.0-5.0 x ULN and AST 2.5-5.0 x ULN; Acceptable medical history; Negative pregnancy test; Stable clinical conditions. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Incapacity to give the informed consent; Previous treatment with TPV interrupted due to intolerance e/o toxicity; Fully or partial genotypic or phenotypic resistance to Aptivus; Any unresolved AIDS defining illness; In the opinion of the investigator, likely survival of less than 12 months because of underlying conditions; Patients with known moderate or severe hepatic insufficiency Child-Pugh Class B or C ; Female patient of child bearing potential who o Has a positive serum pregnancy test at screening or during the study, o Is breast feeding, o Is planning to become pregnant, o Is not willing to use barrier method protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the different incidence of virologic failure between the two groups after 48 weeks from randomization.;Secondary Objective: Proportion of patients with HIV pVL 400 copies/ml after 48 weeks in both treatment groups Proportion of patients without any bleeps in both groups; Proportion of patients with TPV phenotypic cut-off 1.2xWT IC50 at 72 weeks; Changes from baseline in CD4 and CD4 cells count; Time to virological failure; Proportion of Group B failed patients and changes of VL after the opportunity to switch back to 500/200mg dose.;Primary end point(s): proporzione di pazienti con HIV pVL 50 copie/ml dopo 48 settimane in ambedue i gruppi di trattamento | — |
Countries
Italy
Outcome results
None listed