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 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2014-09-15
Summary
Objectives of the study were to evaluate the efficacy and safety of two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two different doses of TPV in combination with RTV for efficacy and safety.
Conditions
- HIV Infections
Interventions
- DRUG
-
Tipranavir (TPV) low dose
- DRUG
-
Tipranavir (TPV) high dose
- DRUG
-
Ritonavir low dose
- DRUG
-
Ritonavir high dose
- DRUG
-
Saquinavir
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-12-31
- Primary Completion
- 2001-11-30
More Related Trials
-
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
NCT00144287 ·Status: COMPLETED ·Phase: PHASE3
-
Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People
NCT00028366 ·Status: COMPLETED ·Phase: NA
-
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
-
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
-
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
NCT00447902 ·Status: TERMINATED ·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
-
Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection
NCT00097799 ·Status: APPROVED_FOR_MARKETING
-
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
-
Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
NCT00035932 ·Status: COMPLETED ·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
-
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
NCT00275444 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
NCT00435929 ·Status: COMPLETED ·Phase: PHASE1
-
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
NCT00389207 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
NCT00135395 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
NCT00027339 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects
NCT00146328 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
NCT00002239 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug Resistance
NCT00046033 ·Status: COMPLETED ·Phase: PHASE2
-
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
NCT00004580 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
NCT00038636 ·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