Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children (PENTA 13)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PENTA Foundation
ClinicalTrials.gov Identifier:
NCT01982396
First received: October 25, 2013
Last updated: November 5, 2013
Last verified: November 2013

October 25, 2013
November 5, 2013
January 2003
February 2004   (final data collection date for primary outcome measure)
  • Area Under Curve (AUC) of lamivudine after qd and bid dosing [ Time Frame: week 0 and Week 4 ] [ Designated as safety issue: No ]
  • Cmin of lamivudine after qd and bid dosing [ Time Frame: week 0 and week 4 ] [ Designated as safety issue: No ]
  • Cmax of lamivudine after qd and bid dosing [ Time Frame: week 0 and week 4 ] [ Designated as safety issue: No ]
  • AUC of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ] [ Designated as safety issue: No ]
  • Cmin of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ] [ Designated as safety issue: No ]
  • Cmax of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01982396 on ClinicalTrials.gov Archive Site
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens [ Time Frame: Week 0 and week 4 ] [ Designated as safety issue: No ]
Same as current
To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing [ Time Frame: week -2 and week 24 ] [ Designated as safety issue: No ]
Same as current
 
Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children
Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: ABC Twice Daily
  • Drug: ABC Once Daily
  • Drug: 3TC Once Daily
  • Drug: 3TC Twice Daily
  • Active Comparator: Twice daily
    Interventions:
    • Drug: ABC Twice Daily
    • Drug: 3TC Twice Daily
  • Experimental: Once daily
    Interventions:
    • Drug: ABC Once Daily
    • Drug: 3TC Once Daily

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
March 2004
February 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children with definitive HIV infection
  • Age > 2 and < 13 years
  • Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.

Exclusion Criteria:

  • • Intercurrent illness

    • Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
    • Abnormal renal or liver function (grade 3 or above)
Both
2 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01982396
PENTA 13
No
PENTA Foundation
PENTA Foundation
Not Provided
Principal Investigator: Vas Novelli, MD Great Ormond Street Hospital for Children, London, UK
Principal Investigator: Hermione Lyall, MD St. Mary's Hospital, London, UK
PENTA Foundation
November 2013

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