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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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: ABC Twice Daily
Drug: ABC Once Daily
Drug: 3TC Once Daily
Drug: 3TC Twice Daily
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

Resource links provided by NLM:


Further study details as provided by PENTA Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: January 2003
Study Completion Date: March 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Twice daily Drug: ABC Twice Daily Drug: 3TC Twice Daily
Experimental: Once daily Drug: ABC Once Daily Drug: 3TC Once Daily

  Eligibility

Ages Eligible for Study:   2 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01982396

Locations
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
PENTA Foundation
Investigators
Principal Investigator: Vas Novelli, MD Great Ormond Street Hospital for Children, London, UK
Principal Investigator: Hermione Lyall, MD St. Mary's Hospital, London, UK
  More Information

Additional Information:
Publications:
Responsible Party: PENTA Foundation
ClinicalTrials.gov Identifier: NCT01982396     History of Changes
Other Study ID Numbers: PENTA 13
Study First Received: October 25, 2013
Last Updated: November 5, 2013
Health Authority: United Kingdom: Department of Health

Keywords provided by PENTA Foundation:
HIV
paediatric
Abacavir
lamivudine

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

ClinicalTrials.gov processed this record on November 24, 2014