PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
NCT ID: NCT01973439
Last Updated: 2014-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2006-07-31
2009-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abacavir Once versus Twice Daily
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)
Intervention 1: PK assessment while on Twice Daily Abacavir
Week 0
Intervention 2: PK assessment while on Once Daily Abacavir
Week 4
Interventions
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Intervention 1: PK assessment while on Twice Daily Abacavir
Week 0
Intervention 2: PK assessment while on Once Daily Abacavir
Week 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Receiving concomitant therapy except prophylactic antibiotics
* Abnormal renal or liver function (grade 3 or above)
3 Months
36 Months
ALL
No
Sponsors
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PENTA Foundation
NETWORK
Responsible Party
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Locations
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Hôpital Port Royal
Paris, , France
Hôpital Robert Debré
Paris, , France
Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
Munich, , Germany
Clinica Pediatrica, Università di Padova
Padua, , 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
Countries
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References
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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.
Other Identifiers
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2005-004433-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PENTA15
Identifier Type: -
Identifier Source: org_study_id
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