HIV infection. MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: PREZISTA*60CPR RIV 400MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DARUNAVIR
CAS Number: 206361-99-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult HIV+ subjects (>18 years old), giving and signing an informed consent; • Any HAART treatment for at least 12 months; • Current treatment with a PI/r-containing regimen initiated at least 6 months earlier; • HIV-RNA 100 cell/uL; • eGFRs >60 mL/min/1,73 m2. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: • Previous drug resistance genotypic test showing the presence of any RPV (RT: K101E/P, E138A/G/K/Q/R, V179L, Y181C/I/V, Y188L, H221Y, F227C, M230I/L) or DRV (protease: V11I, V32I, L33F, I47V, I50V, I54M/L, T74P, L76V, I84V, L89V) resistance associated mutation (RAM), according to the November 2011 IAS-USA list; • Child-Pugh C or grade 3-4 AST or ALT values; • Acute cardiovascular event within 6 months; • AIDS event within 6 months; • Current IVDU; • HBsAg + ; • Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the virologic efficacy of a maintenance regimen with RPV+DRV/r in HIV+ subjects with a previous antiretroviral treatment and a full HIV-RNA suppression.;Secondary Objective: • To evaluate VACS index modification in subjects treated in two groups, at Weeks 48 and 96, as compared to the baseline; • To evaluate differences of markers of tubulopathy (RBP, RBP/creatinine, plasmatic and urinary phosphate, albuminuria) in two groups at week 12, 48, and 96 as compared to the baseline; we report urinary RBP abnormalities in some patients treated with tenofovir, in some studies, and the significance of RBP as an indirect marker of tubular damage; • To evaluate differences of markers of lipid metabolism (total cholesterol, HDL and LDL cholesterol, triglycerides); • To evaluate differences of markers of bone metabolism (osteocalcin, CTx) as compared to baseline; • To evaluate darunavir and rilpivirine plasma exposure (Ctrough) as a determinant of virological failure.;Primary end point(s): HIV+ subjects with HIV-RNA < 50 cp/mL at week 48 according to the intention-to-treat (ITT-TLOVR) approach.;Timepoint(s) of evaluation of this end point: Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety will be assessed through the number of ACTG grade III and IV in the specified safety parameters.;Timepoint(s) of evaluation of this end point: Weeks 12, 48 and 96. | — |
Countries
Italy
Contacts
Public ContactU.O. Malattie Infettive III
Ospedale Luigi Sacco
Outcome results
None listed