Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
NCT01374802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2015-07-31
Summary
The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.
Conditions
- HIV Infections
Interventions
- DRUG
-
Darunavir
400 mg tablet for oral administration
- DRUG
-
Ritonavir
tablet for oral administration
- DRUG
-
BI 201335
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2011-07-31
Countries
- Germany
Study Locations
More Related Trials
-
Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers
NCT03864406 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Low-dose Darunavir in a Switch Study
NCT02671383 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals
NCT00034866 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects
NCT01047995 ·Status: COMPLETED ·Phase: PHASE1
-
TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions
NCT01052883 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
NCT00543101 ·Status: COMPLETED ·Phase: PHASE4
-
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
NCT00000733 ·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
-
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
NCT02063360 ·Status: COMPLETED ·Phase: PHASE1
-
The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers
NCT03094507 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
NCT00534352 ·Status: COMPLETED ·Phase: PHASE2
-
Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy
NCT01606722 ·Status: COMPLETED
-
Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.
NCT03813979 ·Status: WITHDRAWN ·Phase: PHASE4
-
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
NCT01391013 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
NCT00458302 ·Status: COMPLETED ·Phase: PHASE3
-
Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
NCT00056641 ·Status: COMPLETED ·Phase: PHASE2
-
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
NCT00530920 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
NCT00524368 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.
NCT00985543 ·Status: COMPLETED ·Phase: PHASE1
-
A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
NCT00855335 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults
NCT00179335 ·Status: COMPLETED
-
Pharmacokinetic Characteristics and Anti-Inflammatory Effects of Aprepitant In HIV-Infected Subjects
NCT02154360 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
NCT04630002 ·Status: COMPLETED ·Phase: PHASE1
-
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