HIV-Infection MedDRA version: 19.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Prezista
Product Name: Darunavir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DARUNAVIR monoethanolat
CAS Nu
Sponsors
Technische Universitaet Muenchen Fakultaet fuer Medizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • HIV- infection with HIV- RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant women and nursing mothers • Chronic HBV infection (HBsAg positive); known anti-HBsAb > 10 IU/ml within the last 36 months or a history of infection with known anti-HBcAb positive AND anti-HBsAb > 10 IU/ml AND HBsAg-loss are not exclusionary) • Any evidence of a Center for Disease Control and Prevention (CDC) Category C disease at screening, except cutaneous Kaposi’s sarcoma not requiring systemic therapy. Historical or current CD4 cell counts 35% direct bilirubin) • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) • Subjects with severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification • Anticipated need for interferon-based Hepatitis C virus (HCV) therapy during the study • Participation in other interventional clinical trials at the same time • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator • Persons held in an institution by legal or official order • Imprisoned people, people requiring in-house treatment for psychiatric disorders or people who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The clinical trial investigates whether a switch strategy of dual therapy with DRV/r + DTG is non-inferior with respect to HIV RNA < 50 cps/ml (ITTe analysis, FDA snapshot analysis (missing, switch or discontinuation of investigational study drugs for any reason = failure; change of NRTI backbone combination will not be classified as failure for primary endpoint analysis)) to a continuous standard of care therapy with DRV/r in combination with 2 NRTIs (ABC/3TC, F/TDF or F/TAF) over 48 weeks in HIV patients, who are on at least 24 weeks prior to randomisation of a stable and fully suppressive ART, consisting of 2 NRTI (ABC/3TC, F/TDF or F/TAF) in combination with DRV/r for a period of at least 28 days prior to randomisation (HIV RNA < 50 cps/ml and within a period of 24 weeks prior to randomisation with one accepted blip of HIV- RNA < 200 cps/ml). ; Secondary Objective: Number (%) of patients with HIV RNA < 50 cps/ml at week 24 Number (%) of patients with HIV RNA < 200 cps/ml at weeks 24, 48 Immunological response (change in CD4 cell count) at week 24 and 48 Safety and tolerability o Changes in renal function (incl. serum creatinine, CKD-EPI-, MDRD eGFR-, Cystatin-C-eGFR, albumin/creatinine-ratio, proteinuria and beta-2-microglobulin in serum) o Changes in lipids, insulin (HOMA-IR, QUICKI) resistance and glucose metabolism o Incidence of Grade 3-4 adverse events (AE) and AR (CTC AE catalogue) o Psychological and psychosocial Assessment Pharmacokinetic substudy I (PK I, 10/160 subjects in interventional arm at estimated 5 centers) o DTG and DRV serum levels 0, 1, 2, 4, 8, 12 hours after intake of medication; only week 4 Pharmacokinetic substudy II (PK II, 50/160 subjects in interventional arm) o DTG and DRV serum level at a single time poin | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Patients will take medication over a time period of 48 weeks. Patients will be investigated for a total of 6 times during treatment; Secondary end point(s): Number (%) of patients with HIV RNA < 50 cps/ml at week 24 Number (%) of patients with HIV RNA < 200 cps/ml at weeks 24, 48 Immunological response (change in CD4 cell count) at week 24 and 48 Safety and tolerability o Changes in renal function (incl. serum creatinine, CKD-EPI-, MDRD eGFR, Cystatin-C-GFR, albumin/creatinine-ratio, proteinuria and beta-2-microglobulin in serum) o Changes in lipids, insulin (HOMA-IR, QUICKI) resistance and glucose metabolism o Incidence of Grade 3-4 adverse events (AEs) and AR (CTC AE catalogue) o Psychological and psychosocial Assessment Pharmacokinetic Substudy I (PK I, 10/160 subjects in interventional arm at estimated 5 centers) o DTG and DRV serum levels 0, 1, 2, 4, 8, 12 hours after intake of medication; week 4 Pharmacokinetic Substudy II (PK II, 50/160 subjects in interventional arm) o DTG and DRV serum levels at single time point; week 4, 12 and 24 Self reported adherence | — |
Countries
Germany
Contacts
Public ContactHelen Bidner
Münchner Studienzentrum
Outcome results
None listed