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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Other: Intervention 1: PK assessment while on Twice Daily Abacavir
* Other: Intervention 2: PK assessment while on Once Daily Abacavir


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Abacavir Once versus Twice Daily<br>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) | Other: Intervention 1: PK assessment while on Twice Daily Abacavir<br>* Week 0<br>* Other names: ABC;Other: Intervention 2: PK assessment while on Once Daily Abacavir<br>* Week 4<br>* Other names: ABC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abacavir, Lamivudine, Pharmacokinetics, HIV