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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: April 3, 2014
Last verified: April 2014
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 
Overall Participants Analyzed 
[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
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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 ]

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
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Time Frame 48 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    DRV/Rtv
Total, other (not including serious) adverse events   
# participants affected / at risk   18/21 (85.71%) 
Blood and lymphatic system disorders   
Neutropenia † 1   
# participants affected / at risk   2/21 (9.52%) 
Cardiac disorders   
Tachycardia † 1   
# participants affected / at risk   2/21 (9.52%) 
Ear and labyrinth disorders   
Ear pain † 2   
# participants affected / at risk   2/21 (9.52%) 
Gastrointestinal disorders   
Diarrhoea † 2   
# participants affected / at risk   5/21 (23.81%) 
Vomiting † 2   
# participants affected / at risk   4/21 (19.05%) 
Dental caries † 2   
# participants affected / at risk   2/21 (9.52%) 
General disorders   
Pyrexia † 1   
# participants affected / at risk   3/21 (14.29%) 
Infections and infestations   
Otitis media acute † 1   
# participants affected / at risk   2/21 (9.52%) 
Pharyngitis † 1   
# participants affected / at risk   2/21 (9.52%) 
Upper respiratory tract infection † 2   
# participants affected / at risk   6/21 (28.57%) 
Tinea capitis † 2   
# participants affected / at risk   5/21 (23.81%) 
Nasopharyngitis † 2   
# participants affected / at risk   4/21 (19.05%) 
Impetigo † 2   
# participants affected / at risk   3/21 (14.29%) 
Rhinitis † 2   
# participants affected / at risk   3/21 (14.29%) 
Lower respiratory tract infection † 2   
# participants affected / at risk   2/21 (9.52%) 
Otitis media chronic † 2   
# participants affected / at risk   2/21 (9.52%) 
Tinea faciei † 2   
# participants affected / at risk   2/21 (9.52%) 
Tonsillitis † 2   
# participants affected / at risk   2/21 (9.52%) 
Varicella † 2   
# participants affected / at risk   2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 2   
# participants affected / at risk   5/21 (23.81%) 
Nasal congestion † 2   
# participants affected / at risk   3/21 (14.29%) 
Rhinorrhoea † 2   
# participants affected / at risk   3/21 (14.29%) 
Skin and subcutaneous tissue disorders   
Rash † 2   
# participants affected / at risk   3/21 (14.29%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1
2 Term from vocabulary, MedDRA Version 12.1



  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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