At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Darunavir +2 moredrug
Likely dose
Darunavir 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)
In Brief
A Phase 1 clinical trial evaluating Darunavir, Ritonavir, and 1 other intervention for HIV Infections. Completed, enrolled 14 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionJul 2011
TodayJul 2026
First PostedJun 16, 2011
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.0 years ago
Interventions
Darunavirdrug
400 mg tablet for oral administration
Ritonavirdrug
tablet for oral administration
BI 201335drug