HIV-1 infection on an effective ARV therapy (HIV-RNA < copies/ml) MedDRA version: 20.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862
Conditions
Interventions
Trade Name: REZOLSTA - 800 MG/ 150 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE-FLACONE (HDPE)- 30 COMPRESSE
Product Name: darunavir+cobicistat
Pharmaceutical Form: Film-coated tablet
Trade Name: EDUR
Sponsors
AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written signed and dated informed consent to participate in the study must be given by the subject, in accordance with the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E627 and applicable regulations, before completing any procedure related to the study. 2. HIV-1 documented infection 3. Male and female subjects ¿ 18 years of age. 4. Males, or non-pregnant, non-lactating females of childbearing potential, as demonstrated by a negative pregnancy test, who agree to comply with any applicable contraceptive requirements of the protocol. 5. Being on a stable therapy for at least 6 months. 6. SBR must be based on any 2NRTI plus a third NNRTI, PI or INI agent. Any possible registered drug is allowed among NRTI (e.g. tenofovir, lamivudine, emtricitabine and abacavir), PI (e.g. lopinavir, atazanavir, darunavir), NNRTI (efavirenz, nevirapine, rilpivirine) or INI (raltegravir, elvitegravir, dolutegravir). 7. Having a fully suppressed HIV replication as documented by 2 prior HIV-RNA tests (at least two months apart) below the detection limit (50 copies/ml). 8. Subjects and investigator must agree that participation in this study is in the best interest of the subject. 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patients co-infected with HBV 2. Pregnancy or breast feeding. 3. Positive anamnesis for allergy to NNRTI 4. A positive historical genotypic test showing resistance-inducing mutation either toward NNRTIs or PIs 5. History or other evidence of severe illness (malignancy or OI) requiring active treatment and/or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study. 6. Subjects with current or prior (previous year) history of alcohol or other substance abuse. 7. Patients who have previously been screened for or enrolled into this study and subsequently withdrawn. 8. Patients having been given investigational drugs within 12 weeks prior to screening. 9. Inability or unwillingness to provide informed consent. 10. Life expectancy < 18 months 11. Anticipated need for Hepatitis C virus (HCV) therapy during the study period 12. Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses 13. All conditions and medicinal products listed in contraindications of DRV/c and rilpivirine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of rilpivirine as substitutive agent for the nucleosidic backbone within a dual therapy including darunavir/cobicistat in virologic suppressed patients;Secondary Objective: •Immunologic response after therapy switch •Incidence and severity of adverse events (AEs) over time •Incidence and severity of laboratory abnormalities over time Number and type of resistance mutations in case of virologic failure •Incidence of disease progression in terms of HIV-associated conditions, AIDS]and death •Medication adherence over time To quantify bone alteration by ultrasound scan (substudy) ;Primary end point(s): Being the primary goal of the study the efficacy analysis of the rilpivirine-boosted PI combination, the primary end-point will be the proportion of patients that will present a HIV-RNA < 50 copies/ml. The primary end point will be evaluated according to snapshot analysis at 24 weeks according to an ITT NC = failure approach in which all randomized patients will be included and considered failures independently of the reason they did not complete the follow-up. The sample size has been calculated on this end-point ;Timepoint(s) of evaluation of this end point: 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The proportion of patients with viral load < 50 copies/ml at 48 weeks according to snapshot analysis on ITT population. A cumulative uncontrolled analysis will be performed on all patients having the 24 week response as goal. A further 48 week analysis will be performed on patients in the former experimental group. 2) The changes (absolute and percentage) in CD4+ and CD8+. Cell counts will be used to evaluate immunologic response after rilpivirine introduction compared to the continuous SBR 3) The proportion of patients developing resistance-conferring mutations (to any drug class) will be analyzed and cumulatively described throughout the study period 4) The absolute changes as well as proportion of patients above clinically relevant thresholds will be used to evaluate the change of metabolic parameters or chemical parameters over time 5) A descriptive analysis of all reported AEs and a quantitative analysis of AEs leading to treatment interruption/change will be used to evaluate long-term tolerability of the simplification treatment 6) Absolute changes as well as proportion of patients above clinically relevant thresholds will be used to evaluate change over time of bone mineral density ;Timepoint(s) of evaluation of this end point: 24 and 48 week | — |
Countries
Italy
Contacts
Public Contactresponsabile studio
ASST Papa Giovanni XXIII
Outcome results
None listed