A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
NCT00144105 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 562
Last updated 2013-11-01
Summary
Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients
Conditions
- HIV Infections
Interventions
- DRUG
-
TPV500mg/RTV200mgBID
- DRUG
-
TPV500mg/RTV100mgBID
- DRUG
-
LPV400mg/RTV100mgBID
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim Study Coordinator
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-02-29
- Primary Completion
- 2006-11-30
Countries
- Argentina
- Australia
- Brazil
- Canada
- Colombia
- France
- Germany
- Mexico
- Poland
- Romania
- Russia
- Spain
- Thailand
- The Bahamas
- United Kingdom
Study Locations
More Related Trials
-
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
NCT00447902 ·Status: TERMINATED ·Phase: PHASE3
-
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
NCT00110877 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals
NCT00034866 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
NCT00025727 ·Status: UNKNOWN ·Phase: PHASE3
-
TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
NCT00071097 ·Status: COMPLETED ·Phase: PHASE2
-
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
NCT00054717 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
NCT02251145 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.
NCT01237444 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects
NCT02251223 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients
NCT02239835 ·Status: TERMINATED ·Phase: PHASE2
-
TDM of Generic Lopinavir/Ritonavir 200/50 mg
NCT00802334 ·Status: COMPLETED ·Phase: PHASE2
-
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
NCT00933205 ·Status: APPROVED_FOR_MARKETING
-
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
NCT00896051 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
NCT01620944 ·Status: TERMINATED ·Phase: PHASE3
-
Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People
NCT00028366 ·Status: COMPLETED ·Phase: NA
-
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
NCT00838162 ·Status: COMPLETED ·Phase: PHASE2
-
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
NCT00028301 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Effect of Tipranavir and Ritonavir or Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Zidovudine in Healthy Volunteers
NCT02249416 ·Status: COMPLETED ·Phase: PHASE1
-
Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients
NCT02238314 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects
NCT00262522 ·Status: COMPLETED ·Phase: PHASE3
-
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
NCT00004578 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
NCT00654147 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
NCT00358917 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients
NCT03664440 ·Status: COMPLETED ·Phase: NA