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PRotease-Inhibitors MOnotherapy Strategies as maintenance therapy in persons with fully suppressed HIV replication: results from an open-label randomized.

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Presentation on theme: "PRotease-Inhibitors MOnotherapy Strategies as maintenance therapy in persons with fully suppressed HIV replication: results from an open-label randomized."— Presentation transcript:

1 PRotease-Inhibitors MOnotherapy Strategies as maintenance therapy in persons with fully suppressed HIV replication: results from an open-label randomized comparative trial. PRIMO Trial A. Ammassari

2 S ECONDARY O BJECTIVES 1. To compare safety and tolerability of a treatment simplification regimen by a LPV/r or DRV/RTV monotherapy versus a triple PI-based combination therapy. 2. To compare the immune response in terms of changes in the CD4 cell count from baseline over 48 weeks 3. To compare incidence of viral rebound in different treatment groups. 4. To compare the frequency of development of at least one new mutations in RT and PR gene 5. To compare changes in HIV-DNA from baseline to 24, 48, and 96 weeks 6. To compare changes in laboratory parameters at all time points from baseline to 48 weeks in different treatment Groups 7. To evaluate and compare the subject-reported adherence and quality of life (QoL) at baseline and the evolution of adherence and QoL over 48 weeks in treatment groups 8. To compare the antiretroviral drug treatment cost over 48 weeks in all treatment groups P RIMARY O BJECTIVES To compare the efficacy of different maintenance strategies based on PIr monotherapy (LPV/r or DRV/RTV) in HIV-1 infected persons with fully suppressive PI/r-based therapy.

3 Taking 2 NRTI + PI/r at screening Unchanged HAART for at least 6 months HIV RNA <50 copies/mL for at least 12 months CD4 nadir >100 cell/mmc, and CD4 >200 cell/mmc at screenng No history of virological failure to PI/r 4, 8, 12, 24, 36, 48 weeks 48 wks Primary Endpoint: HIV RNA< 50 at week 48 (TLOVR). Per Protocol, Switch = Failure 2 consecutive HIV RNA > 50 copies/mL Stopping LPV/r (Group 2) or DRV/r (Group 3) Starting NRTIs in the monotherapy arm Stopping NRTIs in the triple therapy arm (switches in NRTIs are permitted in arm A). Follow-up phase 48 weeks 1:1:1 randomization 375 subjects SOC (2 NRTI+PI/r) cont. LPV/r 800/200 mg QD Follow-up phase 48 weeks SC 30 days BL DRV/r 800/100 mg QD Follow-up phase 48 weeks PRIMO Trial

4 Study Population I NCLUSION C RITERIA At least 18 years Receiving unchanged HAART regimen including two NRTIs and PI/boosted for at least 24 weeks Plasma HIV-RNA <40 copies/mL for at least 48 weeks prior the screening (two results must be documented) Nadir CD4 >100 cell/mmc, and CD4>200 cell/mmc at screening No previous history of suspected or confirmed virological failure on PI Signed and dated written informed consent SPECIFIC EXCLUSION CRITERIA History of any primary PI mutations as defined by the IASUSA guidelines 2008 Positive HBsAg or HCV infection for which specific treatment is ongoing or planned Diagnosis of acute viral hepatitis at screening Previous history of intolerance to LPV/r or DRV/RTV leading to treatment disc Acute opportunistic infection requiring treatment (exclusion period: 30 days) Mycobacteriosis under treatment Malignancy requiring chemotherapy or radiotherapy

5 Sub-studies Pharmacoeconomc sub-study Pharmacokinetic sub-study HIV-DNA sub-study HIV resistance sub-study Residual HIV viremia substudy Metabolic sub-study (with DEXA) Adherence & QoL sub-study (with MEMS) Neurocognitive sub-study Immunological/immunoactivation/inflammatory response

6 Study Population N°centri clinici partecipanti: 9 N°centri clinici con approvazione del Comitato Etico: 7 N° pazienti arruolati: 106 N° pazienti randomizzati: 94

7 LPV/rDRV/rLPV/rDRV/rLPV/rDRV/r TRUVADACOMBIVIRKIVEXA Costo /mese Costo /anno Costo /mese Costo /anno Costo /mese Costo /anno KALETRA PREZISTA PREZISTA REYATAZ300/r TELZIR/r Risparmio paziente-anno ( ) in base al regime di provenienza

8 RISPARMIO PAZIENTE-ANNO LPV/RTV (n=125)DRV/RTV (n=125) KALETRA.TRUVADA 39% KALTERA.COMBIVIR 19% REYATAZ300/r.TRUVADA 12% TELZIR/r.TRUVADA 12% PREZISTA400/r.TRUVADA 10% Totale per braccio TOTALE RISPARMIO-ANNO Risparmio economico per braccio di trattamento e totale nellambito dello studio PRIMO calcolato in base alla distribuzione dei pazienti in relazione al regime di provenienza e ai 12 mesi di follow-up


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