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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PENTA Foundation
ClinicalTrials.gov Identifier:
NCT01973439
First received: October 25, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
HIV Infection
Other: Intervention 1: PK assessment while on Twice Daily Abacavir
Other: Intervention 2: PK assessment while on Once Daily Abacavir
Phase 1

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

Resource links provided by NLM:


Further study details as provided by PENTA Foundation:

Primary Outcome Measures:
  • Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

  • Cmax of Abacavir on Twice Daily Dosing [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

  • AUC(0-24) of Abacavir on Once Daily Dosing [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication

  • Cmax of Abacavir on Once Daily Dosing [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.


Enrollment: 23
Study Start Date: July 2006
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other: Intervention 1: PK assessment while on Twice Daily Abacavir
Week 0
Other Names:
  • Ziagen
  • ABC
Other: Intervention 2: PK assessment while on Once Daily Abacavir
Week 4
Other Names:
  • Ziagen
  • ABC

  Eligibility

Ages Eligible for Study:   3 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973439

Locations
France
Hôpital Robert Debré
Paris, France
Hôpital Port Royal
Paris, France
Germany
Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
Munich, Germany
Italy
Clinica Pediatrica, Università di Padova
Padova, Italy, 35128
Spain
Hospital Universitario
Getafe, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Gregorio Maranon
Madrid, Spain
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
St. Mary's Hospital
London, United Kingdom
Evelina Children's Hospital
London, United Kingdom
Sponsors and Collaborators
PENTA Foundation
  More Information

Additional Information:
Publications:
Responsible Party: PENTA Foundation
ClinicalTrials.gov Identifier: NCT01973439     History of Changes
Other Study ID Numbers: PENTA15, 2005-004433-18
Study First Received: October 25, 2013
Results First Received: December 4, 2013
Last Updated: February 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PENTA Foundation:
HIV
Abacavir
Lamivudine
Pharmacokinetics

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014