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)

November 5, 2013 updated by: PENTA Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • St. Mary's Hospital
      • London, United Kingdom
        • Great Ormond Street Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Twice daily
Drug: ABC Twice Daily
Drug: 3TC Twice Daily
Experimental: Once daily
Drug: ABC Once Daily
Drug: 3TC Once Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve (AUC) of lamivudine after qd and bid dosing
Time Frame: week 0 and Week 4
week 0 and Week 4
Cmin of lamivudine after qd and bid dosing
Time Frame: week 0 and week 4
week 0 and week 4
Cmax of lamivudine after qd and bid dosing
Time Frame: week 0 and week 4
week 0 and week 4
AUC of abacavir after qd and bid dosing
Time Frame: week 0 and week 4
week 0 and week 4
Cmin of abacavir after qd and bid dosing
Time Frame: week 0 and week 4
week 0 and week 4
Cmax of abacavir after qd and bid dosing
Time Frame: week 0 and week 4
week 0 and week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens
Time Frame: Week 0 and week 4
Week 0 and week 4

Other Outcome Measures

Outcome Measure
Time Frame
To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing
Time Frame: week -2 and week 24
week -2 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PENTA 13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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