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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Intervention 1: PK assessment while on Twice Daily Abacavir
Intervention 2: PK assessment while on Once Daily Abacavir
Sponsored by
PENTA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, Abacavir, Lamivudine, Pharmacokinetics

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Port Royal
  • Hôpital Robert Debré
  • Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
  • Clinica Pediatrica, Università di Padova
  • Hospital Universitario
  • Hospital 12 de Octubre
  • Hospital Gregorio Maranon
  • Birmingham Heartlands Hospital
  • Evelina Children's Hospital
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Abacavir Once versus Twice Daily

Arm Description

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)

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2013
Last Updated
February 3, 2014
Sponsor
PENTA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01973439
Brief Title
PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PENTA Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, Abacavir, Lamivudine, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abacavir Once versus Twice Daily
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Intervention 1: PK assessment while on Twice Daily Abacavir
Other Intervention Name(s)
Ziagen, ABC
Intervention Description
Week 0
Intervention Type
Other
Intervention Name(s)
Intervention 2: PK assessment while on Once Daily Abacavir
Other Intervention Name(s)
Ziagen, ABC
Intervention Description
Week 4
Primary Outcome Measure Information:
Title
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
Description
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Time Frame
Week 0
Title
Cmax of Abacavir on Twice Daily Dosing
Description
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Time Frame
Week 0
Title
AUC(0-24) of Abacavir on Once Daily Dosing
Description
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Time Frame
Week 4
Title
Cmax of Abacavir on Once Daily Dosing
Description
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Hôpital Port Royal
City
Paris
Country
France
Facility Name
Hôpital Robert Debré
City
Paris
Country
France
Facility Name
Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
City
Munich
Country
Germany
Facility Name
Clinica Pediatrica, Università di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Hospital Universitario
City
Getafe
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Evelina Children's Hospital
City
London
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20516550
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.
Results Reference
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PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months

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