A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00838162
First received: February 5, 2009
Last updated: June 3, 2013
Last verified: June 2013
Results First Received: January 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Type 1
Interventions: Drug: TMC310911 75 mg twice daily
Drug: TMC310911 150 mg twice daily
Drug: TMC310911 300 mg twice daily
Drug: TMC310911 300 mg once daily
Drug: Ritonavir 100 mg twice daily
Drug: Ritonavir 100 mg once daily

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 41 participants were screened of whom 33 participants were randomized and treated with TMC310911. All treated participants completed the study; there were no dropouts or discontinuations during the study.

Reporting Groups
  Description
TMC310911/Rtv 75/100 mg Twice Daily TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/Rtv 150/100 mg Twice Daily TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/Rtv 300/100 mg Twice Daily TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/Rtv 300/100 mg Once a Day TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14

Participant Flow:   Overall Study
    TMC310911/Rtv 75/100 mg Twice Daily     TMC310911/Rtv 150/100 mg Twice Daily     TMC310911/Rtv 300/100 mg Twice Daily     TMC310911/Rtv 300/100 mg Once a Day  
STARTED     9     8     8     8  
COMPLETED     9     8     8     8  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
TMC310911/Rtv 75/100 mg Twice Daily TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/Rtv 150/100 mg Twice Daily TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/Rtv 300/100 mg Twice Daily TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/Rtv 300/100 mg Once a Day TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
Total Total of all reporting groups

Baseline Measures
    TMC310911/Rtv 75/100 mg Twice Daily     TMC310911/Rtv 150/100 mg Twice Daily     TMC310911/Rtv 300/100 mg Twice Daily     TMC310911/Rtv 300/100 mg Once a Day     Total  
Number of Participants  
[units: participants]
  9     8     8     8     33  
Age  
[units: years]
Mean ± Standard Deviation
  29.7  ± 7.23     38.1  ± 8.66     35.5  ± 6.87     37.8  ± 10.19     35.1  ± 8.65  
Gender  
[units: participants]
         
Female     1     0     0     0     1  
Male     8     8     8     8     32  
Race/Ethnicity, Customized  
[units: Participants]
         
White     8     8     8     8     32  
Black     1     0     0     0     1  



  Outcome Measures
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1.  Primary:   Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)   [ Time Frame: Baseline (Day 1), Day 8, Day 15 ]

2.  Secondary:   Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period   [ Time Frame: 14 days ]

3.  Secondary:   Mean Changes From Baseline in CD4+ Cell Count   [ Time Frame: Baseline (Day 1), Day 8, Day 15 ]

4.  Secondary:   Maximum Plasma Concentration (Cmax) of TMC310911   [ Time Frame: Day 1 and Day 14 ]

5.  Secondary:   Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911   [ Time Frame: Day 1 and Day 14 ]

6.  Secondary:   Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing   [ Time Frame: Day 1 and Day 14 ]

7.  Secondary:   Predose Plasma Concentration (C0h) of TMC310911   [ Time Frame: Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14 ]

8.  Secondary:   Average Steady-state Plasma Concentration (Css,av) of TMC310911   [ Time Frame: Day 14 ]

9.  Secondary:   Fluctuation Index of TMC310911   [ Time Frame: Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: VP Head of Discovery & Early Development
Organization: Jan-Cil UK
phone: 44 1494 553458
e-mail: ksimmen1@its.jnj.com


No publications provided


Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00838162     History of Changes
Other Study ID Numbers: CR015952, TMC310911-TIDP21-C201, 2008-008190-58
Study First Received: February 5, 2009
Results First Received: January 30, 2013
Last Updated: June 3, 2013
Health Authority: Ireland: Irish Agriculture and Food Development Authority
Germany: Ethics Commission