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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

NCT01982396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-11-13

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infection

Interventions

DRUG

ABC Twice Daily

DRUG

ABC Once Daily

DRUG

3TC Once Daily

DRUG

3TC Twice Daily

Sponsors & Collaborators

  • PENTA Foundation

    lead NETWORK

Principal Investigators

  • Vas Novelli, MD · Great Ormond Street Hospital for Children, London, UK

  • Hermione Lyall, MD · St. Mary's Hospital, London, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2004-02-29
Completion
2004-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01982396 on ClinicalTrials.gov