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

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ClinicalTrials.gov Identifier: NCT01973439
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : March 20, 2014
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
PENTA Foundation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description

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
Period Title: Overall Study
Started 23
Two Evaluable PK Days 18 [1]
One Evaluable PK Day Only 5 [2]
Completed 18
Not Completed 5
Reason Not Completed
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.
Arm/Group Title Single Arm
Hide Arm/Group Description 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
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
18
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
White 3
Black, African or other 14
Mixed Black/White 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Germany 3
Italy 1
United Kingdom 9
Spain 2
France 3
1.Primary Outcome
Title Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
Hide Description Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Time Frame Week 0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: h*mg/L
10.85
(8.89 to 13.24)
2.Primary Outcome
Title Cmax of Abacavir on Twice Daily Dosing
Hide Description Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Time Frame Week 0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
2.29
(1.80 to 2.91)
3.Primary Outcome
Title AUC(0-24) of Abacavir on Once Daily Dosing
Hide Description Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: h*mg/L
11.57
(9.89 to 13.53)
4.Primary Outcome
Title Cmax of Abacavir on Once Daily Dosing
Hide Description Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
4.68
(3.86 to 5.67)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abacavir Once Versus Twice Daily
Hide Arm/Group Description This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4)
All-Cause Mortality
Abacavir Once Versus Twice Daily
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abacavir Once Versus Twice Daily
Affected / at Risk (%)
Total   4/23 (17.39%) 
Gastrointestinal disorders   
Vomiting  1/23 (4.35%) 
Diarrhoea  1/23 (4.35%) 
Infections and infestations   
Croup Infectious  1/23 (4.35%) 
Gastroenteritis Bacteria  1/23 (4.35%) 
Injury, poisoning and procedural complications   
Skin Laceration  1/23 (4.35%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abacavir Once Versus Twice Daily
Affected / at Risk (%)
Total   0/23 (0.00%) 
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.
Results Point of Contact
Name/Title: Trial manager
Organization: MRC Clinical Trials Unit at UCL
Phone: 02076704825
Responsible Party: PENTA Foundation
ClinicalTrials.gov Identifier: NCT01973439     History of Changes
Other Study ID Numbers: PENTA15
2005-004433-18 ( EudraCT Number )
First Submitted: October 25, 2013
First Posted: October 31, 2013
Results First Submitted: December 4, 2013
Results First Posted: March 20, 2014
Last Update Posted: March 20, 2014