Clinical trial NCT01982396: Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children
Official title: Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infection
Keywords: HIV
paediatric
Abacavir
lamivudine
Lead sponsor: PENTA Foundation
Sponsor class: NETWORK
First posted: 2013-11-13
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.


Eligibility criteria: Inclusion Criteria:

* Children with definitive HIV infection
* Age \> 2 and \< 13 years
* Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.

Exclusion Criteria:

* • Intercurrent illness

  * Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
  * Abnormal renal or liver function (grade 3 or above)

Primary outcomes:
measure: Area Under Curve (AUC) of lamivudine after qd and bid dosing
timeFrame: week 0 and Week 4
measure: Cmin of lamivudine after qd and bid dosing
timeFrame: week 0 and week 4
measure: Cmax of lamivudine after qd and bid dosing
timeFrame: week 0 and week 4
measure: AUC of abacavir after qd and bid dosing
timeFrame: week 0 and week 4
measure: Cmin of abacavir after qd and bid dosing
timeFrame: week 0 and week 4
measure: Cmax of abacavir after qd and bid dosing
timeFrame: week 0 and week 4
Secondary outcomes:
measure: To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens
timeFrame: Week 0 and week 4
Other outcomes:
measure: To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing
timeFrame: week -2 and week 24
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Great Ormond Street Hospital for Children, London, UK
name: Vas Novelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary's Hospital, London, UK
name: Hermione Lyall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Prevost M, Walker S, Novelli V, Lyall H, Khoo S, Gibb D; PENTA-13 Study Group. Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antivir Ther. 2005;10(2):239-46.
citation: LePrevost M, Green H, Flynn J, Head S, Clapson M, Lyall H, Novelli V, Farrelly L, Walker AS, Burger DM, Gibb DM; Pediatric European Network for the Treatment of AIDS 13 Study Group. Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children. Pediatr Infect Dis J. 2006 Jun;25(6):533-7. doi: 10.1097/01.inf.0000222415.40563.d4.