PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PENTA Foundation
ClinicalTrials.gov Identifier:
NCT01973439
First received: October 25, 2013
Last updated: February 3, 2014
Last verified: February 2014
Results First Received: December 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Other: Intervention 1: PK assessment while on Twice Daily Abacavir
Other: Intervention 2: PK assessment while on Once Daily 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
No text entered.

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
Single Arm

This is a single arm crossover study

  1. st intervention: PK assessment while on Twice Daily Abacavir
  2. nd intervention: PK assessment while on Once Daily Abacavir

Participant Flow:   Overall Study
    Single Arm  
STARTED     23  
Two Evaluable PK Days     18 [1]
One Evaluable PK Day Only     5 [2]
COMPLETED     18  
NOT COMPLETED     5  
Lost samples from one PK Day                 2  
Vomiting after commencing once daily                 1  
PK curve incomplete                 2  
[1] 18 Children had two evaluable PK days
[2] 5 children had only one evaluable PK day.



  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
Single Arm This is a single arm crossover study First intervention: PK assessment while on Twice Daily Abacavir Second intervention: PK assessment while on Once Daily Abacavir

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
  18  
Age  
[units: participants]
 
<=18 years     18  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     8  
Male     10  
Race/Ethnicity, Customized  
[units: participants]
 
White     3  
Black, African or other     14  
Mixed Black/White     1  
Region of Enrollment  
[units: participants]
 
Germany     3  
Italy     1  
United Kingdom     9  
Spain     2  
France     3  



  Outcome Measures
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1.  Primary:   Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing   [ Time Frame: Week 0 ]

2.  Primary:   Cmax of Abacavir on Twice Daily Dosing   [ Time Frame: Week 0 ]

3.  Primary:   AUC(0-24) of Abacavir on Once Daily Dosing   [ Time Frame: Week 4 ]

4.  Primary:   Cmax of Abacavir on Once Daily Dosing   [ Time Frame: Week 4 ]


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


Results Point of Contact:  
Name/Title: Trial manager
Organization: MRC Clinical Trials Unit at UCL
phone: 02076704825
e-mail: silvia.forcat@ucl.ac.uk


Publications:

Responsible Party: PENTA Foundation
ClinicalTrials.gov Identifier: NCT01973439     History of Changes
Other Study ID Numbers: PENTA15, 2005-004433-18
Study First Received: October 25, 2013
Results First Received: December 4, 2013
Last Updated: February 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices