HIV infection MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862
Conditions
Interventions
Trade Name: NORVIR*FL 84CPS MOLLI 100MG
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
OSPEDALE S. RAFFAELE DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: documented HIV infection, age> 18 years,patients treated with a PI-based regimen for at least 48 weeks, virologic suppression (HIV RNA 200/µL, CD4+ nadir> 100 / uL. 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 295 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: any time feedback of primary mutations for darunavir (47V, 50V, 54L / M, 76V, 84V) for lopinavir (32I, 47A / V, 76V, 82A/F/S/T) or > 3 among the following: 10I/F/R/V, 11I, 20M / R, 24I, 33F, 46I / L, 53L, 54A/S/T/V, 63P, 71T / V, 73S, 74P, 89V, 90M; previous virological failure (at least 2 consecutive HIV RNA> 50 copies / mL) during treatment with PI, liver cirrhosis Child-Pugh B or C, acute hepatitis in progress, HCV co-infection for which is in progress or planned a treatment with interferon and ribavirin during the following 48 weeks, active HBV infection (HBsAg positive), pregnancy or lactation in place (or planned for the 48 weeks later), an event defining AIDS in progress, neoplasia requiring chemotherapy or radiation therapy, participation in another clinical trial, subjects that ,in the opinion of the investigator, are unable to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate the non-inferiority of two different regimes of simplification of HAART monotherapy with PI / r (darunavir / ritonavir and lopinavir / ritonavir) compared to HAART therapy in patients with HIV infection treated with any regimen PI based and viral replication completely suppressed.;Secondary Objective: comparison of changes on: lipid profile, insulin resistance, kidney and liver function, mineral bone density, distribution of subcutaneous fat, neurocognitive performance, immune activation and immune recostruction, incidence of virologic failure.;Primary end point(s): proportion of patients with virologic failure (> 50 copies of Ml RNA) in two consecutive determinations at least 2 weeks apart;Timepoint(s) of evaluation of this end point: week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a. | — |
Countries
Italy
Contacts
Public ContactMalattie Infettive
Ospedale San Raffaele
Outcome results
None listed