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Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT01374802
Recruitment Status : Completed
First Posted : June 16, 2011
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Darunavir
Drug: Ritonavir
Drug: BI 201335

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects

The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.

Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).

Period 2: Faldaprevir together with DRV/r.


Participant Flow:   Overall Study
    All Subjects
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.

Reporting Groups
  Description
All Subjects

The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.

Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).

Period 2: faldaprevir together with DRV/r.


Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.4  (9.9) 
Gender 
[Units: Participants]
 
Female   2 
Male   12 


  Outcome Measures

1.  Primary:   AUCτ,ss of Darunavir   [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) ]

2.  Primary:   Cτ,ss of Darunavir   [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) ]

3.  Primary:   Cmax,ss of Darunavir   [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) ]

4.  Secondary:   Tmax,ss of Darunavir   [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01374802     History of Changes
Other Study ID Numbers: 1220.49
2011-000505-41 ( EudraCT Number: EudraCT )
First Submitted: June 8, 2011
First Posted: June 16, 2011
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015