3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
NCT00275444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2023-12-01
Summary
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
Conditions
- HIV Infections
Interventions
- DRUG
-
Tipranavir
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim Study Coordinator · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-03-29
- Primary Completion
- 2003-01-20
Countries
- United States
- Australia
- Canada
- France
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom
Study Locations
More Related Trials
-
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
-
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
NCT02251145 ·Status: COMPLETED ·Phase: PHASE1
-
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
NCT00530920 ·Status: COMPLETED ·Phase: PHASE2
-
Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection
NCT00097799 ·Status: APPROVED_FOR_MARKETING
-
Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients
NCT02238314 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
NCT00447902 ·Status: TERMINATED ·Phase: PHASE3
-
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
-
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
NCT00110877 ·Status: COMPLETED ·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
-
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
-
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects
NCT00144833 ·Status: TERMINATED ·Phase: PHASE3
-
Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI
NCT00517192 ·Status: TERMINATED ·Phase: PHASE3
-
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
-
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
-
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
NCT00076999 ·Status: COMPLETED ·Phase: PHASE1
-
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
NCT00258557 ·Status: COMPLETED ·Phase: PHASE3
-
Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
NCT01605084 ·Status: WITHDRAWN ·Phase: PHASE3
-
Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects
NCT00344123 ·Status: COMPLETED ·Phase: PHASE1
-
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
NCT00440271 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
NCT01705574 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
NCT00357188 ·Status: COMPLETED ·Phase: PHASE1
-
ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
NCT00004582 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir
NCT02253836 ·Status: COMPLETED ·Phase: PHASE1