Clinical trial NCT01973439: PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infection
Keywords: HIV
Abacavir
Lamivudine
Pharmacokinetics
Lead sponsor: PENTA Foundation
Sponsor class: NETWORK
First posted: 2013-10-31
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Intercurrent illness
* Receiving concomitant therapy except prophylactic antibiotics
* Abnormal renal or liver function (grade 3 or above)

Primary outcomes:
measure: Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
timeFrame: Week 0
measure: Cmax of Abacavir on Twice Daily Dosing
timeFrame: Week 0
measure: AUC(0-24) of Abacavir on Once Daily Dosing
timeFrame: Week 4
measure: Cmax of Abacavir on Once Daily Dosing
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Port Royal
city: Paris
country: France
facility: Hôpital Robert Debré
city: Munich
country: Germany
facility: Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
city: Padova
country: Italy
facility: Clinica Pediatrica, Università di Padova
city: Getafe
country: Spain
facility: Hospital Universitario
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: London
country: United Kingdom
facility: Evelina Children's Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
References:
citation: 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.