| 1 |
NCT03101644 |
Recruiting |
Optimization of Darunavir Therapy and Dosage Recommendations |
- Human Immunodeficiency Virus I Infection
|
|
Interventional |
Phase 4 |
- Université Catholique de Louvain
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Darunavir clearance
- Darunavir volume of distribution
- Darunavir absorption rate
- (and 6 more...)
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT03101644 |
UCL-LB-02 |
|
March 23, 2017 |
September 2018 |
September 2018 |
April 5, 2017 |
April 26, 2017 |
|
- Cliniques universitaires Saint-Luc
Brussels, Belgium
|
| 2 |
NCT02384967 |
Completed |
Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients |
|
|
Interventional |
Phase 2 |
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with therapeutic success, defined as no virological failure
- Proportions of patients with virological failure (confirmed VL > 50 cp/ml)
- Proportions of patients with VL < 50 cp/ml
- (and 8 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02384967 |
ANRS 165 DARULIGHT |
DARULIGHT |
March 2015 |
October 2016 |
October 2016 |
March 10, 2015 |
January 24, 2017 |
|
- Hôpital Saint Louis
Paris, France
|
| 3 |
NCT02671383 |
Recruiting |
Evaluation of Low-dose Darunavir in a Switch Study |
|
- Drug: Darunavir
- Drug: Lopinavir
|
Interventional |
Phase 3 |
- Willem Daniel Francois Venter
- Medical Research Council, South Africa
- University of Witwatersrand, South Africa
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with undetectable HIV-1 RNA levels
- Number of participants with certain adverse events related to the treatment
- Time to virologic failure
|
300 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT02671383 |
WRHI052 |
DRV |
July 2016 |
September 2017 |
September 2017 |
February 2, 2016 |
July 12, 2016 |
|
- Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
|
| 4 |
NCT01606722 |
Completed |
Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy |
|
- Drug: Darunavir/ritonavir
|
Observational |
|
- Hospitales Universitarios Virgen del Rocío
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Virological efficacy
- Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation
|
150 |
All |
18 Years to 65 Years (Adult) |
NCT01606722 |
LLC-DAR-2010-01 |
MonDar |
January 2010 |
June 2013 |
June 2013 |
May 28, 2012 |
July 11, 2013 |
|
- Hospital Universitarios Virgen del Rocio
Seville, Spain
|
| 5 |
NCT02503462 |
Terminated |
Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals |
- AIDS-related Dementia Complex
|
- Drug: Darunavir
- Drug: ritonavir
- Drug: cobicistat
|
Interventional |
Phase 4 |
- University Hospital, Basel, Switzerland
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cerebrospinal fluid/plasma concentrations (ng/ml) of darunavir/ritonavir versus darunavir/cobicistat
- Cerebrospinal fluid concentrations (ng/ml) of darunavir/ritonavir versus darunavir/cobicistat relative to the concentration of darunavir (ng/ml) inhibiting 50% (IC50) or 90% (IC90) of the viral replication
- Proportion of responders (HIV RNA < 50 copies/ml in CSF) for darunavir/ritonavir versus darunavir/cobicistat
|
7 |
All |
18 Years and older (Adult, Senior) |
NCT02503462 |
DRVCOBI |
|
July 2015 |
January 2017 |
January 2017 |
July 21, 2015 |
February 2, 2017 |
|
- Division of Infectious Diseases, University Hospital Basel
Basel, BS, Switzerland
|
| 6 |
NCT03123848 |
Completed |
A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants |
|
- Drug: Darunavir/Cobicistat
|
Interventional |
Phase 4 |
- Janssen Pharmaceutical K.K.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Maximum Observed Plasma Concentration (Cmax)
- Concentration at Last Quantifiable Time Point (Clast)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
- (and 5 more...)
|
8 |
All |
20 Years to 55 Years (Adult) |
NCT03123848 |
CR108319
TMC114FD1HTX4002 |
|
April 14, 2017 |
May 19, 2017 |
May 19, 2017 |
April 21, 2017 |
June 19, 2017 |
|
- Souseikai Hakata Clinic
Fukuoka, Japan
|
| 7 |
NCT02404233 |
Unknown † |
Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects |
|
- Drug: darunavir/cobicistat
- Drug: rilpivirine
|
Interventional |
Phase 4 |
- Therapeutic Concepts
- Janssen Scientific Affairs, LLC
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with plasma HIV-1 RNA <50 copies/mL
- Proportion of patients with plasma HIV-1 RNA <400 copies/mL at each time point evaluated
- Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02404233 |
TMC278HIV4003 |
PREZENT |
March 2015 |
September 2016 |
December 2016 |
March 31, 2015 |
March 31, 2015 |
|
- Therapeutic Concepts, P.A.
Houston, Texas, United States - Therapeutic Concepts, PA
Houston, Texas, United States
|
| 8 |
NCT02159599 |
Completed |
Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject |
|
- Drug: Darunavir/Ritonavir
- Drug: Lamivudine
- Drug: Emtricitabine/tenofovir or abacavir/lamivudine
|
Interventional |
Phase 4 |
- Fundacion SEIMC-GESIDA
- Janssen, LP
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of patients with undetectable viral load
- Proportion of patients with viral load < 200 copies/ml
- Proportion of patients who present viral load ≥ 50 copies /ml one time
- (and 6 more...)
|
249 |
All |
18 Years and older (Adult, Senior) |
NCT02159599 |
GESIDA 8014
2014-000515-14 |
DUAL |
July 2014 |
April 2016 |
April 2016 |
June 10, 2014 |
February 14, 2017 |
|
- Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain - Hospital General Universitario de Alicante
Alicante, Spain - Hospital Universitario Germans Trias i Pujol
Badalona, Spain - (and 18 more...)
|
| 9 |
NCT01375881 |
Completed |
Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice |
|
- Drug: darunavir/ritonavir plus background regimen
|
Observational |
|
|
Industry |
- Observational Model: Cohort
|
- Measurement of viral load, as an assessment of efficacy
- Immunological response, as measured by CD4 cells count
- Impact on Health-related Quality of Life after switching to a darunavir containing regimen in accordance to the approved indication
- (and 3 more...)
|
31 |
All |
18 Years and older (Adult, Senior) |
NCT01375881 |
CR017641
TMC114HIV4042 |
|
June 2009 |
December 2012 |
December 2012 |
June 17, 2011 |
May 6, 2013 |
|
|
| 10 |
NCT01047995 |
Completed |
Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects |
|
- Drug: Raltegravir plus Darunavir/ritonavir
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Steady state plasma and intracellular concentrations of darunavir/ritonavir once daily with and without raltegravir and raltegravir twice and once daily
- Safety and tolerability of darunavir/ritonavir and raltegravir when co-administered to HIV-infected subjects
- Association between genetic polymorphisms in drug disposition genes and drug exposure
|
26 |
All |
18 Years to 65 Years (Adult) |
NCT01047995 |
SSAT 031
2008-008321-30 |
|
June 2009 |
December 2009 |
December 2009 |
January 13, 2010 |
January 13, 2010 |
|
- St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom - St Stephens Centre, Chelsea & Westminster Hospital
London, United Kingdom
|
| 11 |
NCT00885495 |
Unknown † |
Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study |
|
- Drug: darunavir, ritonavir, rosuvastatin
- Drug: rosuvastatin, darunavir, ritonavir
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To investigate the effect of darunavir/ritonavir on the pharmacokinetics of rosuvastatin.
- To investigate the effect of rosuvastatin on the steady state pharmacokinetics of darunavir/ritonavir.
- To compare the change in low-density lipoprotein (LDL) cholesterol with rosuvastatin therapy alone, darunavir/ritonavir therapy alone and with the co-administration of rosuvastatin and darunavir/ritonavir.
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT00885495 |
IDC 40 |
|
January 2009 |
June 2009 |
August 2009 |
April 22, 2009 |
April 22, 2009 |
|
- University of Cincinnati AIDS Clinical Trials Unit
Cincinnati, Ohio, United States
|
| 12 |
NCT00855088 |
Completed |
Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue |
|
- Drug: darunavir
- Drug: Ritonavir
- Drug: Etravirine
|
Interventional |
Phase 1 |
- University of North Carolina, Chapel Hill
- Tibotec Pharmaceutical Limited
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- To generate individual pharmacokinetic parameters for darunavir, ritonavir, and etravirine in seminal plasma after single and multiple dosing
- To generate composite pharmacokinetic parameters for darunavir, ritonavir, and etravirine in rectal tissue after single and multiple dosing
- To generate matrix:blood plasma ratios of darunavir, ritonavir, and etravirine in semen and rectal tissue after single and multiple dosing
|
13 |
Male |
18 Years to 49 Years (Adult) |
NCT00855088 |
UNC IRB 08-0419 |
DESeRT |
July 2009 |
February 2010 |
February 2011 |
March 4, 2009 |
May 13, 2011 |
|
- UNC Hospitals CTRC
Chapel Hill, North Carolina, United States
|
| 13 |
NCT01541085 |
Completed |
An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART |
- Human Immunodeficiency Virus; HIV
|
- Drug: Darunavir/Ritonavir (DRV/r)
- Drug: Efavirenz (EFV)
|
Observational |
|
|
Industry |
- Time Perspective: Retrospective
|
- Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
- Change in peripheral T-lymphocyte immune phenotype
- Change in peripheral T-lymphocyte turnover
|
33 |
All |
30 Years to 50 Years (Adult) |
NCT01541085 |
CR017920
TMC114HIV0010 |
|
December 2011 |
June 2013 |
June 2013 |
February 29, 2012 |
November 26, 2013 |
|
|
| 14 |
NCT02199613 |
Completed |
Elvitegravir/Cobicistat/Tenofovir DF/Emtricitabine With Darunavir Treatment Simplification Strategy |
|
- Drug: Treatment simplification
|
Interventional |
Phase 4 |
- University of British Columbia
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Plasma HIV RNA
- plasma HIV RNA
- CD4 cell count, CD4% and CD4/CD8 ratio
- (and 8 more...)
|
10 |
All |
19 Years and older (Adult, Senior) |
NCT02199613 |
H14-00490 |
QuaDar |
October 2014 |
February 14, 2017 |
February 14, 2017 |
July 24, 2014 |
November 6, 2017 |
|
- St. Paul's Hospital Immunodeficiency Clinic
Vancouver, British Columbia, Canada
|
| 15 |
NCT01869634 |
Completed |
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART |
- Human Immunodeficiency Virus Infection
|
- Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Interventional |
Phase 4 |
- University of California, Davis
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Recovery of CD4 T-lymphocytes in GALT
- To measure the change in cardiovascular risk
|
37 |
All |
21 Years and older (Adult, Senior) |
NCT01869634 |
394080
IIS RFA _Asmuth:TMC114HIV2029 |
|
June 2013 |
December 2016 |
December 2016 |
June 5, 2013 |
May 30, 2017 |
|
- University of California Davis
Sacramento, California, United States
|
| 16 |
NCT01695954 |
Unknown † |
Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz |
|
- Drug: Pitavastatin
- Drug: Darunavir
- Drug: Ritonavir
- Drug: Efavirenz
|
Interventional |
Phase 1 |
- New York University School of Medicine
- Bellevue/NYU AIDS Clinical Trials Unit
- Kowa Pharmaceuticals America, Inc.
- University at Buffalo
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- AUC of pitavastatin after coadministration of efavirenz. AUC of pitavastatin after coadministration of darunavir with ritonavir. AUC of efavirenz after coadministration of pitavastatin. AUC of darunavir after coadministration of pitavastatin.
- Other pharmacokinetic parameters of pitavastatin and efavirenz and of pitavastatin and darunavir+ritonavir. Lipid measurements at days 0,4,14 and 18.
|
28 |
All |
18 Years to 60 Years (Adult) |
NCT01695954 |
NYU 11-01787 |
|
May 2012 |
October 2012 |
October 2012 |
September 28, 2012 |
September 28, 2012 |
|
- Bellevue/NYU AIDS Clinical Trials Unit
New York, New York, United States
|
| 17 |
NCT02818348 |
Completed |
Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients |
|
- Drug: darunavir/cobicistat
- Drug: etravirine
|
Interventional |
Phase 1 |
- Fundacio Lluita Contra la SIDA
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Darunavir, cobicistat and etravirine concentrations in plasma
- Grade ≥3 adverse events and serious adverse events
- HIV-1 RNA load in plasma
|
30 |
All |
18 Years to 64 Years (Adult) |
NCT02818348 |
DRV/c-ETR |
|
June 2016 |
October 2016 |
November 23, 2016 |
June 29, 2016 |
March 12, 2018 |
|
- Fundació Lluita contra la SIDA
Badalona, Barcelona, Spain
|
| 18 |
NCT01741831 |
Completed |
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista |
- Acquired Immune Deficiency Syndrome
|
|
Observational |
|
- Janssen Korea, Ltd., Korea
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Number of patients with adverse events
- Number of patients with viral load
- Number of patients with CD4 T-cell count
|
225 |
All |
18 Years and older (Adult, Senior) |
NCT01741831 |
CR100805
TMC114HIV4074
Prezista PMS
DRV-C-11-KR-001-V06 |
|
July 2012 |
October 2016 |
October 2016 |
December 5, 2012 |
December 5, 2016 |
|
- Dae-Gu, Korea, Republic of
|
| 19 |
NCT02499978 |
Withdrawn |
Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity |
|
- Drug: Darunavir/Cobicistat
- Drug: Dolutegravir
|
Interventional |
Phase 2
Phase 3 |
- Stanford University
- Janssen Scientific Affairs, LLC
- University of Colorado, Denver
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Virologic suppression (24 weeks)
- Virologic Suppression (48 weeks)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02499978 |
deNUC |
TMC114HIV2030 |
May 2016 |
June 2016 |
June 2016 |
July 16, 2015 |
October 31, 2016 |
|
- Stanford Univerity
Stanford, California, United States - University of Colorado
Aurora, Colorado, United States
|
| 20 |
NCT02337322 |
Recruiting |
Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir |
- Acquired Immune Deficiency Syndrome Virus
|
- Drug: Dolutegravir
- Drug: Darunavir/r
|
Interventional |
Phase 4 |
- Juan A. Arnaiz
- Hospital Clinic of Barcelona
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Median CD4 T cell count increase
|
108 |
All |
18 Years and older (Adult, Senior) |
NCT02337322 |
Advanz-4 |
|
March 31, 2015 |
December 2019 |
December 2019 |
January 13, 2015 |
April 13, 2018 |
|
- Hospital Clinic of Barcelona
Barcelona, BCN, Spain
|
| 21 |
NCT01423812 |
Completed
Has Results |
DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects |
|
- Drug: Twice-daily Darunavir and ritonavir
- Drug: Once-daily Darunavir and ritonavir
|
Interventional |
Phase 4 |
- Ruth M. Rothstein CORE Center
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects
- Secondary Efficacy Endpoints
- Safety Assessment
- (and 3 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT01423812 |
TMC114HIV4063 |
DRIVESHAFT |
January 2012 |
May 2014 |
April 2015 |
August 26, 2011 |
February 7, 2018 |
February 7, 2018 |
- Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
|
| 22 |
NCT01367210 |
Terminated |
Switch to Darunavir/r + Maraviroc Quaque Die in Patients With R5 Tropism by Viral DNA Genotyping (GUSTA) |
|
- Drug: Maraviroc, Darunavir/r
- Drug: current antiretroviral therapy with 3 drugs
|
Interventional |
Phase 4 |
- Catholic University of the Sacred Heart
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure
- proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure
- Time to virological failure at survival analysis
- (and 9 more...)
|
165 |
All |
18 Years and older (Adult, Senior) |
NCT01367210 |
2010-023316-13 |
GUSTA |
June 2011 |
June 2015 |
June 2015 |
June 7, 2011 |
February 8, 2016 |
|
- Catholic University of Sacred Heart
Rome, Italy
|
| 23 |
NCT03094507 |
Active, not recruiting |
The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers |
|
- Drug: Tivicay
- Drug: Rezolsta
|
Interventional |
Phase 1 |
- St Stephens Aids Trust
- ViiV Healthcare
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Assess the pharmacokinetics of dolutegravir and darunavir/cobicistat during co-administration in HIV negative healthy volunteers as measured by Cthrough
- Assess the pharmacokinetics of dolutegravir and darunavir/cobicistat during co-administration in HIV negative healthy volunteers as measured by Cmax
- Assess the pharmacokinetics of dolutegravir and darunavir/cobicistat during co-administration in HIV negative healthy volunteers as measured by t1/2
- (and 7 more...)
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT03094507 |
SSAT073 |
SSAT073 |
April 19, 2017 |
April 2018 |
August 2018 |
March 29, 2017 |
October 31, 2017 |
|
- St Stephen's Centre
London, United Kingdom
|
| 24 |
NCT01046890 |
Completed |
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir |
|
|
Interventional |
Phase 4 |
- Germans Trias i Pujol Hospital
- IrsiCaixa
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- plasma concentration of darunavir and ritonavir
- Clearance (CL/F)
- Volume of distribution (V/F)
- (and 4 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT01046890 |
EQUIDAR |
|
January 2010 |
March 2010 |
April 2010 |
January 12, 2010 |
May 5, 2010 |
|
- Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, Spain
|
| 25 |
NCT01736761 |
Completed |
A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients. |
|
- Drug: Darunavir, Ritonavir and Rilpivirine
|
Interventional |
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Virologic suppression after 48 weeks of therapy with the study regime
- To explore the virologic response to this combination rilpivirine and ritonavir-boosted darunavir at weeks 4, 8, 12 and 24 of therapy.
|
36 |
All |
18 Years to 65 Years (Adult) |
NCT01736761 |
SSAT 049 |
|
December 2012 |
March 2015 |
March 2015 |
November 29, 2012 |
June 16, 2017 |
|
- St Stephen's AIDS Trust
London, United Kingdom
|
| 26 |
NCT01294761 |
Completed |
Comparing Continuing Tenofovir, Emtricitabine (or Lamivudine) Plus Lopinavir and Switching to Raltegravir Plus Darunavir |
|
- Drug: Raltegravir, Darunavir/r
|
Interventional |
Not Applicable |
- National Center for Global Health and Medicine, Japan
- Ministry of Health, Labour and Welfare, Japan
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- eGFR improvement comparison of two arms by ITT analysis
- Virological efficacy
- Renal function markers
- (and 4 more...)
|
59 |
All |
20 Years and older (Adult, Senior) |
NCT01294761 |
FWA00005823-SPARE2011
UMIN000005116 |
SPARE |
February 2011 |
February 2012 |
December 2013 |
February 11, 2011 |
March 30, 2015 |
|
- National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan
|
| 27 |
NCT02589158 |
Completed |
SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat |
|
- Drug: Evotaz
- Drug: Rezolsta
|
Interventional |
Phase 1 |
- St Stephens Aids Trust
- Bristol-Myers Squibb
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the steady-state pharmacokinetics of atazanavir/cobicistat and darunavir/cobicistat over 72 hours, in HIV negative healthy volunteers as measured by Ctrough
- To assess the steady-state pharmacokinetics of atazanavir/cobicistat and darunavir/cobicistat over 72 hours, in HIV negative healthy volunteers, as measured by Cmax
- To assess the steady-state pharmacokinetics of atazanavir/cobicistat and darunavir/cobicistat over 72 hours, in HIV negative healthy volunteers, as measured by t1/2
- (and 7 more...)
|
16 |
All |
18 Years to 65 Years (Adult) |
NCT02589158 |
SSAT067 |
|
November 2015 |
March 2016 |
March 2016 |
October 28, 2015 |
March 22, 2016 |
|
- St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom
|
| 28 |
NCT02187107 |
Completed |
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials |
|
|
Interventional |
Phase 2 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
- Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)
- Change in CD4 cells absolute count
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT02187107 |
CR005848
TMC114-C208 |
|
January 2005 |
September 2005 |
March 2009 |
July 10, 2014 |
August 25, 2014 |
|
- Darlinghurst, Australia
- Wien, Austria
- Gent, Belgium
- (and 8 more...)
|
| 29 |
NCT01258439 |
Completed |
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART. |
- HIV
- Cardiovascular Disease
|
- Drug: raltegravir plus truvada
- Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
|
Interventional |
Phase 4 |
- St Vincent's Hospital, Sydney
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
- safety
- Other metabolic parameters
- Arterial stiffness
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT01258439 |
ROaR+ |
ROaR+ |
November 2010 |
July 2014 |
July 2014 |
December 13, 2010 |
January 12, 2015 |
|
- Holdsworth House Medical Practice
Sydney, New South Wales, Australia - St Vincent Hospital, Clinical Research Program
Sydney, New South Wales, Australia
|
| 30 |
NCT01374802 |
Completed
Has Results |
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers |
|
- Drug: Darunavir
- Drug: Ritonavir
- Drug: BI 201335
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUCτ,ss of Darunavir
- Cτ,ss of Darunavir
- Cmax,ss of Darunavir
- Tmax,ss of Darunavir
|
14 |
All |
18 Years to 55 Years (Adult) |
NCT01374802 |
1220.49
2011-000505-41 |
|
June 2011 |
July 2011 |
|
June 16, 2011 |
July 31, 2015 |
July 31, 2015 |
- 1220.49.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
|
| 31 |
NCT02155101 |
Completed |
Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS |
|
- Drug: Darunavir
- Drug: ART with 2 NRTIs plus LPV/r (or ATV/r)
|
Interventional |
Phase 3 |
- University of Liverpool
- Janssen Pharmaceutica
- Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS
- Yaounde Central Hospital
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
121 |
All |
21 Years to 70 Years (Adult, Senior) |
NCT02155101 |
ChantalIRCB |
MANET |
May 2014 |
June 2016 |
July 2016 |
June 4, 2014 |
June 2, 2017 |
|
- Yaounde Central Hospital
Yaounde, Centre, Cameroon
|
| 32 |
NCT03017872 |
Recruiting |
Dolutegravir and Darunavir Evaluation in Adults Failing Therapy |
|
- Drug: N(t)RTIs
- Drug: Dolutegravir
- Drug: Darunavir
- Drug: Ritonavir
|
Interventional |
Phase 4 |
- Kirby Institute
- UNITAID
- National Health and Medical Research Council, Australia
- (and 2 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of participants in each arm whose plasma viral load is <50 copies/mL at 48 weeks by intention to treat.
- Proportion with plasma viral load <200 copies/mL
- Proportion with plasma viral load <50 copies/mL where those stopping randomised therapy for any reason are classified as plasma viral load >50 copies/mL
- (and 12 more...)
|
610 |
All |
18 Years and older (Adult, Senior) |
NCT03017872 |
D2EFT |
D²EFT |
November 1, 2017 |
September 30, 2019 |
December 30, 2020 |
January 11, 2017 |
January 12, 2018 |
|
- Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Ciudad De Buenos Aires, Argentina - Hospital Nacional Prof Alejandro Posadas
El Palomar, Provincia De Buenos Aires, Argentina - Hospital Dr Diego Paroissien
Isidro Casanova, Provincia De Buenos Aires, Argentina - (and 17 more...)
|
| 33 |
NCT01066962 |
Completed |
Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects |
|
- Drug: darunavir/ritonavir QD + raltegravir BID
- Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
|
Interventional |
Phase 3 |
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- NEAT - European AIDS Treatment Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
|
800 |
All |
18 Years and older (Adult, Senior) |
NCT01066962 |
2009-015113-44 |
ANRS 143 |
August 2010 |
October 2013 |
October 2013 |
February 10, 2010 |
November 6, 2013 |
|
- Allgemeines Krankenhaus der Stadt Wien
Wien, Austria - Otto Wagner Spital mit Pflegezentrum
Wien, Austria - ITZ Antwerpen
Antwerpen, Belgium - (and 74 more...)
|
| 34 |
NCT01346982 |
Completed |
Drug Interactions Between Silimarine and Darunavir/Ritonavir |
|
|
Interventional |
Phase 4 |
- Fundacio Lluita Contra la SIDA
- IrsiCaixa
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of darunavir
- Area under the plasma concentration-time curve during the dosing interval (AUC0-12) of ritonavir
- Darunavir and ritonavir clearance (CL/F)
- (and 4 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT01346982 |
SILIDAR
2010-021159-25 |
|
March 2011 |
July 2011 |
July 2011 |
May 4, 2011 |
September 30, 2011 |
|
- Lluita contra la Sida Foundation, HIV Unit
Badalona, Barcelona, Spain
|
| 35 |
NCT01726348 |
Withdrawn |
A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients |
- Human Immunodeficiency Virus-Type 1
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Number of patients with incidence of adverse events
- Number of patients with incidence of discontinuation of study medication due to adverse events
- Mean decrease of viral load at the end of treatment from baseline
- (and 2 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01726348 |
CR014686
TMC114HIV4013
PRE-PHL-MA1
TMC-C-07-PH-007 |
|
January 2014 |
December 2014 |
December 2014 |
November 14, 2012 |
December 2, 2015 |
|
|
| 36 |
NCT00611039 |
Completed |
Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy |
|
- Drug: Darunavir 900mg + ritonavir 100 mg once a day
- Drug: Darunavir 600mg + ritonavir 100mg twice day
|
Interventional |
Phase 4 |
- Germans Trias i Pujol Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with HIV-1 viral load < 50 copies /mL
- DRV plasma trough concentration
- DRV Virtual inhibitory quotient (vIQ)
- (and 7 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00611039 |
DRV 900100 QD |
DRV900100QD |
February 2008 |
July 2009 |
July 2009 |
February 8, 2008 |
October 6, 2009 |
|
- Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
|
| 37 |
NCT01928407 |
Completed |
Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts |
- HIV-1 Infection
- Immunosuppression-related Infectious Disease
|
- Drug: DARUNAVIR
- Drug: ATAZANAVIR
|
Interventional |
Phase 4 |
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Viral load of HIV-1 < 50 cp/ml
- • Proportion of subjets with virologic efficacy
- • Proportion of subjects with confirmed virologic failure
- (and 10 more...)
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT01928407 |
IMEA 040-DATA |
DATA |
February 23, 2011 |
March 29, 2011 |
January 7, 2013 |
August 26, 2013 |
January 12, 2018 |
|
- Hopital Zobda Quitman
Fort De France, Martinique, France - Centre Hospitalier D'Argenteuil
Argenteuil, France - Hopital Saint-Jacques
Besancon, France - (and 27 more...)
|
| 38 |
NCT01258374 |
Completed |
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients. |
- HIV Integrase, HIV Protease.
|
- Drug: Raltegravir
- Drug: Darunavir
|
Observational |
|
- Hospital Clinic of Barcelona
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
15 |
All |
18 Years to 65 Years (Adult) |
NCT01258374 |
RALDAR-HCB |
RALDAR |
May 2010 |
May 2011 |
December 2011 |
December 13, 2010 |
September 2, 2015 |
|
- Hospital Clinic
Barcelona, Spain
|
| 39 |
NCT00855413 |
Terminated
Has Results |
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine |
- Acute HIV Infection
- HIV Infections
|
- Drug: Darunavir
- Drug: Ritonavir
- Drug: Etravirine
|
Interventional |
Phase 4 |
- University of North Carolina, Chapel Hill
- Janssen Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Virologic Response
- Median Change in CD4 Cell Count From Week 0 to Week 24.
- Median Change in CD4 Cell Count From Week 0 to Week 48.
- (and 34 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT00855413 |
CID 0821 |
|
March 2009 |
November 2013 |
November 2013 |
March 4, 2009 |
October 17, 2017 |
October 17, 2017 |
- The University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States - Duke University
Durham, North Carolina, United States
|
| 40 |
NCT01073761 |
Completed |
Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study |
|
- Drug: darunavir/ritonavir then atazanavir/ritonavir
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetics
- Inter-Subject Variability
- Safety and Tolerability
- Pharmacogenetics
|
25 |
All |
18 Years to 65 Years (Adult) |
NCT01073761 |
SSAT 034 |
|
April 2010 |
June 2010 |
June 2010 |
February 23, 2010 |
August 16, 2010 |
|
- St Stephen's Centre
London, United Kingdom
|
| 41 |
NCT01391013 |
Completed
Has Results |
A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients |
- Human Immunodeficiency Virus 1
|
- Drug: Darunavir(DRV)
- Drug: Ritonavir
- Drug: 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)
- Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)
- Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
- (and 14 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01391013 |
CR017575
TMC114HIV3017
TMC-C-07-IT-016 |
MONARCH |
June 2009 |
April 2011 |
April 2011 |
July 11, 2011 |
June 27, 2013 |
June 27, 2013 |
|
| 42 |
NCT00993148 |
Completed
Has Results |
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 |
- HIV-1 Infection
- HIV Infections
|
- Drug: maraviroc
- Drug: darunavir
- Drug: ritonavir
|
Interventional |
Phase 2 |
- Northwestern University
- Pfizer
- Tibotec, Inc
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Plasma HIV-1 RNA >50
- Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
- Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL
- (and 6 more...)
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT00993148 |
MIDAS |
MIDAS |
May 2010 |
April 2013 |
April 2013 |
October 12, 2009 |
September 5, 2014 |
August 19, 2014 |
- Quest Clinical Research
San Francisco, California, United States - University of Miami
Miami, Florida, United States - Northwestern University
Chicago, Illinois, United States - (and 2 more...)
|
| 43 |
NCT00355524 |
Completed |
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents |
|
- Drug: TMC114
- Drug: Ritonavir
|
Interventional |
Phase 2 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 1
- Predose Plasma Concentration (C0) - Part 1
- Maximum Observed Plasma Concentration (Cmax) - Part 1
- (and 10 more...)
|
80 |
All |
6 Years to 17 Years (Child) |
NCT00355524 |
CR002797
TMC114-C212 |
|
June 2006 |
August 2007 |
March 2011 |
July 24, 2006 |
July 8, 2013 |
|
- Los Angeles, California, United States
- Washington, District of Columbia, United States
- Chicago, Illinois, United States
- (and 19 more...)
|
| 44 |
NCT00964327 |
Completed |
TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains |
|
|
Interventional |
Phase 2 |
- Tibotec Pharmaceuticals, Ireland
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the antiviral activity of TMC114.
- nadir of viral load
- Pharmacokinetics (PK) / Pharmacodynamics (PD): Plasma concentration of TMC114 and efficacy and safety data will be analyzed to find relationships between PK and PD.
- CD4 count
|
42 |
All |
18 Years and older (Adult, Senior) |
NCT00964327 |
CR006718 |
|
August 2001 |
October 2003 |
October 2003 |
August 24, 2009 |
May 19, 2011 |
|
|
| 45 |
NCT00994344 |
Completed |
Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens |
|
- Drug: Darunavir/ritonavir
- Drug: Lopinavir/ritonavir
|
Interventional |
Phase 4 |
- Germans Trias i Pujol Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Plasmatic HIV-1 Viral load
- CD4 cell count
- Changes in liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma GT, alkaline phosphatase)
- (and 9 more...)
|
73 |
All |
18 Years to 65 Years (Adult) |
NCT00994344 |
LOPIDAR |
|
October 2009 |
October 2012 |
October 2012 |
October 14, 2009 |
February 13, 2014 |
|
- Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain - Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canarias, Spain
|
| 46 |
NCT01448707 |
Completed
Has Results |
A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment |
- Human Immunodeficiency Virus (HIV) Infections
- Acquired Immunodeficiency Syndrome (AIDS) Virus
|
- Drug: Darunavir
- Drug: Ritonavir
|
Interventional |
Phase 3 |
- Janssen-Cilag International NV
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)
- Virologic Response (FDA Snapshot, Switch Included)
- Change From Baseline in Global Neurocognitive Performance z-Score
- (and 3 more...)
|
274 |
All |
18 Years and older (Adult, Senior) |
NCT01448707 |
CR018370
TMC114IFD3003
2011-001635-23
PROTEA |
PROTEA |
March 15, 2012 |
June 11, 2014 |
March 18, 2015 |
October 7, 2011 |
November 27, 2017 |
December 3, 2015 |
- Graz, Austria
- Wien, Austria
- Antwerpen, Belgium
- (and 33 more...)
|
| 47 |
NCT01615601 |
Completed |
An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients |
- Human Immunodeficiency Virus (HIV)
|
- Drug: darunavir (PREZISTA)
- Drug: etravirine (INTELENCE)
- Drug: ritonavir
- Drug: Other antiretroviral medications
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change from Baseline in the patient's total score of the HIV Symptom Distress Module (HIV-SDM)
- Number of participants with Maintenance/achievement of virologic suppression at Week 24
- Number of participants with disappearance by Week 4 of at least one bothersome symptom identified at baseline by patient on HIV-SDM
- (and 3 more...)
|
77 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01615601 |
CR018595
TMC114HIV4068 |
POISE |
October 2011 |
April 2013 |
April 2013 |
June 8, 2012 |
May 22, 2014 |
|
|
| 48 |
NCT00531557 |
Completed |
Double Protease Inhibitor to Darunavir Switch Study |
|
- Drug: Darunavir ritonavir
|
Interventional |
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- The proportion of subjects maintaining viral suppression (< 50 copies/mL)
- • CD4+ count at screening, baseline, weeks 4, 12, 24, 36 and at the end of the study period • Viral suppression below 50 copies/mL and below 500 copies/mL at 4, 12, 24, 36 and 48 weeks • Laboratory abnormalities and adverse events at baseline, 4
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT00531557 |
SSAT022 |
|
September 2007 |
November 2008 |
November 2008 |
September 19, 2007 |
August 16, 2010 |
|
- St Stephens Centre, Chelsea & Westminster Hospital
London, United Kingdom
|
| 49 |
NCT00458302 |
Completed
Has Results |
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir |
- HIV Infections
- AIDS Virus
- Human Immunodeficiency Virus
- Acquired Immunodeficiency Syndrome Virus
|
- Drug: darunavir (DRV, TMC114)
|
Interventional |
Phase 3 |
- Janssen-Cilag International NV
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]
- Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]
- Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]
- (and 10 more...)
|
256 |
All |
18 Years and older (Adult, Senior) |
NCT00458302 |
CR013159
TMC114HIV3006
2006-006437-40 |
MONET |
June 2007 |
February 2009 |
January 2011 |
April 10, 2007 |
December 19, 2012 |
February 26, 2010 |
- Wien, Austria
- Antwerpen, Belgium
- Bruxelles, Belgium
- (and 25 more...)
|
| 50 |
NCT00421551 |
Completed |
Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136 |
|
- Drug: Darunavir
- Drug: ritonavir
|
Interventional |
Phase 3 |
- French National Agency for Research on AIDS and Viral Hepatitis
- Tibotec Pharmaceutical Limited
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with virological success, the virological failure is defined as 2 consecutive plasma viral load measurements greater or equal to 400 cp/ml within 2 weeks at W48
- Proportion of patients with virological success between W48 and W96,
- Proportion of patients with HIV-1 RNA below 50 copies/mL, between 50 to 400 copies/mL and > 400 copies/ml from D0 to W96,
- (and 14 more...)
|
225 |
All |
18 Years and older (Adult, Senior) |
NCT00421551 |
2006-005962-38
ANRS 136 MONOI |
|
March 2007 |
June 2010 |
February 2011 |
January 12, 2007 |
July 18, 2013 |
|
- Service des maladies infectieuses et tropicales Hopital Pitie salpetriere
Paris, France
|
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