Human Immunodeficiency Virus Type 1 MedDRA version: 18.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Darunavir 800mg, Cobicistat 150mg, Emtricitabine 200mg, Tenofovir Alefenamide 10mg tablet
Product Code: TMC114 + JNJ-48763364-AAA + JNJ-35807551-AAA + JNJ
Pharmaceutical Form: Film-coate
Sponsors
Janssen R&D, Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor(limited to darunavir [DRV] or atazanavir with low dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv combined with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) only, for at least 6 consecutive months preceding the screening visit. - On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (=) 50 copies per ml after previously reaching viral suppression between 12 and 2 months prior to screening in acceptable, provided a subsequent test prior to Screening was =65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: 1. A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening. 2. Proven or suspected acute hepatitis within 30 days prior to study enter. 3. Hepatitis C antibody positive; however, participants previously cured of hepatitis C virus (HCV) infection, with documented sustained virologic response, that is, undetectable HCV RNA 24 weeks after the last dose of HCV treatment, are allowed to participate. 4. Hepatitis B surface antigen (HBsAg) positive. 5. Participants with cirrhosis as diagnosed based on local practices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate noninferiority in efficacy of a D/C/F/TAF once-daily single-tablet regimen relative to continuing the current bPI combined with FTC/TDF in virologically-suppressed (HIV 1 RNA = 50 copies/ml through Week 48;Timepoint(s) of evaluation of this end point: Up to Week 48;Secondary Objective: -Evaluate superiority of switching to D/C/F/TAF once-daily single-tablet regimen vs continuing current bPI combined with FTC/TDF in regard to proportion of virologic rebounders, in case noninferiority is established -Evaluate proportion of rebounders through Week 24 in 2 treatment arms -Evaluate efficacy as determined by continued suppression of HIV-1 RNA (<20, <50,&<200 HIV-1 RNA copies/mL as defined by FDA snapshot analysis and TLOVR algorithm at Weeks 24&48 in 2 treatment arms -Evaluate safety&tolerability of D/C/F/TAF regimen through 24&48 weeks of treatment -Evaluate change from baseline in serum creatinine, eGFRcr, by CKD-EPI Collaboration and eGFRcyst, by CKD-EPI in 2 treatment arms at Weeks 24&48 -Evaluate change from baseline in renal biomarkers at Weeks 24&48 -Evaluate immunologic changes (CD4+ cell count) through 24&48 weeks of treatment in 2 arms Further secondary objectives, reference is made to Protocol Amend4 section 2 page 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percentage of participants with plasma HIV-1 RNA level < 50 copies/ml at Week 24, 48 and 96 per FDA snapshot approach 2) Percentage of participants with plasma HIV-1 RNA level < 50 copies/ml at Weeks 24, 48 and 96 per TLOVR algorithm 3) Change from baseline in cluster of differentiation (CD) 4+ cell counts at Week 24, 48, and 96 4) Percentage of participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Grade 3 and 4, and premature discontinuations due to AEs 5) Percentage of participants with resistance to ARVs and type of resistance in participants with virologic rebound 6) Change from baseline in serum creatinine, estimated Glomerular Filtration Rate for creatinine clearance (eGFRcr) and eGFR for cystatin-C clearance (eGFRcyst) at week 24, 48 and 96 7) Change from baseline in renal biomarkers at Weeks 24, 48 and 96 8) Percent change from baseline in spine and hip Bone Mineral Density (BMD) at Weeks 24, 48 and 96;Timepoint(s) of evaluation of this end point: 1) Week 24, 48 and 96 2) Week 24, 48 and 96 3) Week 24, 48 and 96 4) Baseline up to Week 24, 48 and 96 5) Baseline Week 24, 48 and 96 6) Up to Weeks 24, 48 and 96 7) Baseline and Week 24, 48 and 96 8) Baseline and Week 24, 48 and 96 | — |
Countries
Belgium, Canada, France, Poland, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed