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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:
ClinicalTrials.gov Identifier:
NCT01982396
First Posted: November 13, 2013
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PENTA Foundation
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
  • Cmin of lamivudine after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • Cmax of lamivudine after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • AUC of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • Cmin of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ]
  • Cmax of abacavir after qd and bid dosing [ Time Frame: week 0 and week 4 ]

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 25, 2013
First Posted: November 13, 2013
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by PENTA Foundation:
HIV
paediatric
Abacavir
lamivudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
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
Lamivudine
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents