A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00919854
First received: June 11, 2009
Last updated: November 19, 2013
Last verified: November 2013
Results First Received: August 3, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus 1
Interventions: Drug: Darunavir
Drug: Ritonavir

  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 5 countries: Argentina, Brazil, India, Kenya, and South Africa.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
27 participants were recruited and treated in this study; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participants), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.

Reporting Groups
  Description
DRV/Rtv Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg

Participant Flow:   Overall Study
    DRV/Rtv  
STARTED     21  
COMPLETED     20 [1]
NOT COMPLETED     1  
Adverse Event                 1  
[1] 'Completed' represents the patients that are ongoing at the time of cut-off for the 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.
No text entered.

Reporting Groups
  Description
DRV/Rtv Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg

Baseline Measures
    DRV/Rtv  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Median ( Full Range )
  4.6  
  ( 3.2 to 5.9 )  
Gender  
[units: participants]
 
Female     11  
Male     10  
Region of Enrollment  
[units: participants]
 
Argentina     4  
Brazil     6  
India     1  
South Africa     10  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  15.1  ± 1.51  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR)   [ Time Frame: Week 24 ]

2.  Secondary:   Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48   [ Time Frame: Week 24 and Week 48 ]

4.  Secondary:   Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48   [ Time Frame: Week 24 and Week 48 ]

5.  Secondary:   Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load   [ Time Frame: Baseline, Week 24 and Week 48 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load
Measure Description No text entered.
Time Frame Baseline, Week 24 and Week 48  
Safety Issue No  

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.
27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.

Reporting Groups
  Description
DRV/Rtv Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg

Measured Values
    DRV/Rtv  
Number of Participants Analyzed  
[units: participants]
  21  
Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load  
[units: log10┬ácopies/mL]
Mean ± Standard Error
 
Week 24     -2.04  ± 0.244  
Week 48     -2.14  ± 0.257  

No statistical analysis provided for Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load



6.  Secondary:   Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage   [ Time Frame: Baseline, Week 24 and Week 48 ]


  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: Senior Director R&D
Organization: Janssen R&D US
phone: 1 609 730-7548


No publications provided


Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00919854     History of Changes
Other Study ID Numbers: CR012553, TMC114-TiDP29-C228
Study First Received: June 11, 2009
Results First Received: August 3, 2011
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration