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

October 25, 2013
February 3, 2014
July 2006
June 2008   (final data collection date for primary outcome measure)
  • 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.
  • Cmax of ABC after qd and bid dosing [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
  • AUC of ABC after qd and bid dosing. [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
  • Cmin of ABC after qd and bid dosing [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01973439 on ClinicalTrials.gov Archive Site
Not Provided
  • AUC of 3TC after qd and bid dosing. [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
  • Cmax of 3TC after qd and bid dosing. [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
  • Cmin of 3TC after qd and bid dosing. [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
  • Assessment of adherence and acceptability with twice and once daily dosage regimens, using questionnaires [ Time Frame: Week 0, week 4, week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
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

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • 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
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)
Interventions:
  • Other: Intervention 1: PK assessment while on Twice Daily Abacavir
  • Other: Intervention 2: PK assessment while on Once Daily Abacavir
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2009
June 2008   (final data collection date for primary outcome measure)

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)
Both
3 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01973439
PENTA15, 2005-004433-18
No
PENTA Foundation
PENTA Foundation
Not Provided
Not Provided
PENTA Foundation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP