A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00905489
First received: May 6, 2009
Last updated: December 2, 2015
Last verified: December 2015
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Nevirapine Immediate Release (IR)
Drug: Nevirapine Extended Release (XR)

  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
Multicenter Phase I study in Botswana, Germany, South Africa and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was only one treatment group and no randomization process. Overall, 90 pediatric patients were enrolled. Five patients were not entered and 85 patients entered the study. Patients were stratified to the following three age groups: (26 in the 3 - <6 year age group, 26 in the 6 - < 12 year age group and 33 in the 12 - < 18 year age group).

Reporting Groups
  Description
Total.

All patients enrolled in study.

All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).


Participant Flow for 2 periods

Period 1:   Pharmaco-kinetic (PK) Phase
    Total.  
STARTED     85  
COMPLETED     80  
NOT COMPLETED     5  
Protocol Violation                 2  
Other reason not defined above                 3  

Period 2:   Optional Extension Phase (OEP)
    Total.  
STARTED     40 [1]
COMPLETED     39  
NOT COMPLETED     1  
Adverse Event                 1  
[1] Includes only subjects who chose to continue trt with nevirapine XR after completing the PK phase.



  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.
Full analysis set (FAS): All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Reporting Groups
  Description
Total.

All patients enrolled in study.

All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).


Baseline Measures
    Total.  
Number of Participants  
[units: participants]
  85  
Age  
[units: years]
Mean (Standard Deviation)
  9.3  (4.6)  
Gender  
[units: participants]
 
Female     47  
Male     38  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Trough Cpre,N.   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

2.  Secondary:   AUCt,ss   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

3.  Secondary:   Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

4.  Secondary:   Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

5.  Secondary:   Ratio Cmax,ss/Cmin,ss   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

6.  Secondary:   %PTF   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

7.  Secondary:   Tmax,ss   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

8.  Secondary:   CL/F,ss   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

9.  Secondary:   Cavg   [ Time Frame: Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR ]

10.  Secondary:   Efficacy: Patients Maintaining a VL < 50 Copies/mL   [ Time Frame: Day 22 ]

11.  Secondary:   Efficacy: Patients Maintaining a VL < 400 Copies/mL   [ Time Frame: Day 22 ]

12.  Secondary:   Change From Baseline in Mean CD4+ Count (Absolute)   [ Time Frame: Baseline, Day 22 and week 24 ]

13.  Secondary:   Percentage Change From Baseline in Mean CD4+ Count   [ Time Frame: Baseline to day 22 and baseline to week 24 ]

14.  Secondary:   Efficacy: Patients Maintaining a VL < 50 Copies/mL at Week 24 of Optional Extension Phase   [ Time Frame: week 24 ]

15.  Secondary:   Efficacy: Patients Maintaining a VL < 400 Copies/mL in Optional Extension Phase   [ Time Frame: week 24 ]

16.  Other Pre-specified:   Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit   [ Time Frame: Last available visit, up to 155 weeks ]


  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00905489     History of Changes
Other Study ID Numbers: 1100.1518
2008-005855-61 ( EudraCT Number: EudraCT )
Study First Received: May 6, 2009
Results First Received: September 23, 2013
Last Updated: December 2, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Republic of Botswana: Ministry of Health
South Africa: MCC (Medicines Control Council)
United States: Food and Drug Administration