PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
PENTA15
PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months
2 other identifiers
interventional
23
5 countries
10
Brief Summary
To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months The secondary objectives of PENTA15 were: To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to \<12 months, ≥12 to \<24 months and ≥24 to \<36 months) To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2006
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
October 31, 2013
CompletedResults Posted
Study results publicly available
March 20, 2014
CompletedMarch 20, 2014
February 1, 2014
1.9 years
October 25, 2013
December 4, 2013
February 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Week 0
Cmax of Abacavir on Twice Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Week 0
AUC(0-24) of Abacavir on Once Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Week 4
Cmax of Abacavir on Once Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
Week 4
Study Arms (1)
Abacavir Once versus Twice Daily
OTHERThis 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)
Interventions
Week 0
Week 4
Eligibility Criteria
You may qualify if:
- Infants and children with confirmed presence of HIV-1 infection
- Infants and children aged 3 to \<36 months
- Parents/guardians able and willing to give written, informed consent
- Currently on combination ART including Abacavir (ABC) oral solution with or without Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.
- HIV-1 RNA viral load either;
- suppressed HIV-1 RNA viral load (i.e. \<400 copies/ml)
- non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen
- Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks.
You may not qualify if:
- Intercurrent illness
- Receiving concomitant therapy except prophylactic antibiotics
- Abnormal renal or liver function (grade 3 or above)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PENTA Foundationlead
Study Sites (10)
Hôpital Port Royal
Paris, France
Hôpital Robert Debré
Paris, France
Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
Munich, Germany
Clinica Pediatrica, Università di Padova
Padua, 35128, Italy
Hospital Universitario
Getafe, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Gregorio Maranon
Madrid, Spain
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Evelina Children's Hospital
London, United Kingdom
St. Mary's Hospital
London, United Kingdom
Related Publications (1)
Paediatric European Network for Treatment of AIDS (PENTA). Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months. Antivir Ther. 2010;15(3):297-305. doi: 10.3851/IMP1532.
PMID: 20516550BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial manager
- Organization
- MRC Clinical Trials Unit at UCL
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
October 31, 2013
Study Start
July 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2009
Last Updated
March 20, 2014
Results First Posted
March 20, 2014
Record last verified: 2014-02