Trial Outcomes & Findings for PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months (NCT NCT01973439)

NCT ID: NCT01973439

Last Updated: 2014-03-20

Results Overview

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 23 participants
• Primary outcome timeframe: Week 0
• Results posted on: 2014-03-20

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	23
Overall Study Two Evaluable PK Days	18
Overall Study One Evaluable PK Day Only	5
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	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
Overall Study Lost samples from one PK Day	2
Overall Study Vomiting after commencing once daily	1
Overall Study PK curve incomplete	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Single Arm n=18 Participants 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
Age, Categorical <=18 years	18 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized White	3 participants n=5 Participants
Race/Ethnicity, Customized Black, African or other	14 participants n=5 Participants
Race/Ethnicity, Customized Mixed Black/White	1 participants n=5 Participants
Region of Enrollment Germany	3 participants n=5 Participants
Region of Enrollment Italy	1 participants n=5 Participants
Region of Enrollment United Kingdom	9 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

Outcome measures

Measure	Single Arm n=18 Participants 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)
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing	10.85 h*mg/L Interval 8.89 to 13.24

PRIMARY outcome

Timeframe: Week 0

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

Outcome measures

Measure	Single Arm n=18 Participants 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)
Cmax of Abacavir on Twice Daily Dosing	2.29 mg/L Interval 1.8 to 2.91

PRIMARY outcome

Timeframe: Week 4

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication

Outcome measures

Measure	Single Arm n=18 Participants 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)
AUC(0-24) of Abacavir on Once Daily Dosing	11.57 h*mg/L Interval 9.89 to 13.53

PRIMARY outcome

Timeframe: Week 4

Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.

Outcome measures

Measure	Single Arm n=18 Participants 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)
Cmax of Abacavir on Once Daily Dosing	4.68 mg/L Interval 3.86 to 5.67

Adverse Events

Abacavir Once Versus Twice Daily

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Abacavir Once Versus Twice Daily n=23 participants at risk 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)
Infections and infestations Croup Infectious	4.3% 1/23
Injury, poisoning and procedural complications Skin Laceration	4.3% 1/23
Infections and infestations Gastroenteritis Bacteria	4.3% 1/23
Gastrointestinal disorders Vomiting	4.3% 1/23
Gastrointestinal disorders Diarrhoea	4.3% 1/23

Other adverse events

Adverse event data not reported

Additional Information

Trial manager

MRC Clinical Trials Unit at UCL

Phone: 02076704825

Email: silvia.forcat@ucl.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60