HIV1-infected adults
Conditions
Interventions
Trade Name: Edurant
Pharmaceutical Form: Coated tablet
Trade Name: Prezista
Pharmaceutical Form: Coated tablet
Trade Name: Norvir
Pharmaceutical Form: Coated tablet
Sponsors
A.O PAPA GIOVANNI XXIII- BERGAMO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV-1 documented infection Age = 18 years Being on a stable HAART regimen based on the association of 2 NRTIs and a boostd-PI for at least 6 months. Being on an effective (VL =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any major NNRTI or PI resistance mutation in an historical genotype Pregnancy or breast-feeding An active malignancy or OI requiring active treatment (prophylactic regimens are allowed) Life expectancy < 18 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of rilpivirine as substitutive agent for the nucleosidic backbone of HAART in virologic suppressed patients. Primary analysis will be performed after 6 months. A further analysis will be performed after a prolonged observation time of 12 months. Efficacy will be defined according to snapshot analysis. ;Secondary Objective: To evaluate immunologic response after rilpivirine introduction To evaluate virologic efficacy using a high sensitivity HIV-RNA test with a limit of detection of 3 copies/ml To evaluate the risk of selecting for resistance-inducing mutations during the simplification therapy by means of a new generation sequencing assay detecting minority species at a 1% prevalence To evaluate the change of metabolic parameters over time and quantify bone alteration by ultrasound scan To evaluate change over time of immunoactivation markers To evaluate long-term tolerability of the simplification treatment ;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 the A secondary analysis will be performed according a per protocol (PP) approach. In this case only patients fulfilling protocol-defined timeline and continuing to assume the randomized therapy will be considered. ;Timepoint(s) of evaluation of this end point: 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy outcome measures (end-points) of this study are: 1) The proportion of patients with viral load < 50 copies/ml at 12 months according to snapshot analysis on both ITT and PP populations and according to a time-dependent analysis of virologic response based on the Kaplan-Meier approach. 2) The changes (absolute and percentage) in CD4+ and CD8+ and CD8+CD38+HLA*DR+ counts. Cell counts will be used to evaluate immunologic response after rilpivirine introduction compared to the continuous SBR 3) The proportion of patients with viral load below the detection limit by means of an ultrasensitive PCR test with a limit of detection of 3 copies/ml. The same evaluation timing as for the primary end-point will used. 4) The proportion of patients developing resistance-conferring mutations (to any drug class) will be analyzed and cumulatively described throughout the study period 5) 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 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 7) 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 ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactFranco Maggiolo
A.O PAPA GIOVANNI XXIII- BERGAMO
Outcome results
None listed