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

HIV Infection Clinical Trial

— PENTA15  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973439
• Other study ID #: PENTA15
• Secondary ID: 2005-004433-18
• Status: Completed
• Phase: Phase 1
• First received: October 25, 2013
• Last updated: February 3, 2014
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: February 2014
• Source: PENTA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Agencia Española de Medicamentos y Productos SanitariosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 36 Months

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Other:
• Intervention 1: PK assessment while on Twice Daily Abacavir
Week 0
• Intervention 2: PK assessment while on Once Daily Abacavir
Week 4

Locations

Country	Name	City	State
France	Hôpital Port Royal	Paris
France	Hôpital Robert Debré	Paris
Germany	Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital	Munich
Italy	Clinica Pediatrica, Università di Padova	Padova
Spain	Hospital Universitario	Getafe
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Gregorio Maranon	Madrid
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Evelina Children's Hospital	London
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
PENTA Foundation

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   Link