A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents (DIONE)

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00915655
First received: June 4, 2009
Last updated: August 28, 2012
Last verified: August 2012
Results First Received: November 25, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: darunavir
Drug: ritonavir
Drug: zidovudine
Drug: lamivudine
Drug: abacavir

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
DRV/Rtv Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.

Participant Flow:   Overall Study
    DRV/Rtv  
STARTED     12  
COMPLETED     12 [1]
NOT COMPLETED     0  
[1] 'Completed' represents patients who have not discontinued at time of cut-off for Week 24 analysis



  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.
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Reporting Groups
  Description
DRV/Rtv Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.

Baseline Measures
    DRV/Rtv  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  14.7  ± 1.69  
Gender  
[units: participants]
 
Female     8  
Male     4  
Percentile for Height  
[units: Height Percentile]
Median ( Full Range )
  27.2  
  ( 0.5 to 94.1 )  
Percentile for BMI  
[units: BMI Percentile]
Median ( Full Range )
  47.5  
  ( 13.3 to 85.9 )  
Percentile for Weight  
[units: Weight Percentile]
Median ( Full Range )
  51.6  
  ( 8.6 to 79.0 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Virological Response[Viral Load <50 Copies/mL, TLOVR]   [ Time Frame: Week 24 ]

2.  Secondary:   Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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 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: Medical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: +1 609 730-7548


No publications provided


Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00915655     History of Changes
Other Study ID Numbers: CR016312, TMC114-TiDP29-C230, 2008-004631-37
Study First Received: June 4, 2009
Results First Received: November 25, 2011
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority