Comparison of Abacavir Following Once-Daily And Twice-Daily Administration In HIV Infected Subjects

October 15, 2008 updated by: GlaxoSmithKline

An Open-Label, Two-Period, Crossover, Pharmacokinetic Study of Abacavir and Its Intracellular Anabolite Carbovir Triphosphate Following Once-Daily and Twice-Daily Administration of Abacavir in HIV-Infected Subjects.

The purpose of the study is to look at the levels of the drug abacavir (ABC) in blood. Also, the study will look at the levels of carbovir triphosphate (CBV-TP), which is the active substance produced from ABC in the bodyâ s cells which helps prevent HIV from multiplying. CBV-TP will be measured in specific blood cells. The amount of ABC and CBV-TP will be looked at when subjects receive ABC as a 300mg dose twice a day and compared with the levels when they receive ABC as a 600mg dose once a day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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, SW10 9TH
        • GSK Investigational Site

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Healthy adults , inclusively.
  • Documented HIV-1 infection (documented by historical data or current validated assay).
  • Undetectable viral load.
  • Currently on an ABC-tablet containing regimen for at least 8 weeks.
  • Willingness to temporarily switch ABC schedule from BID to QD, or vice versa, for 11 days.
  • Weigh between 40-100kg, inclusive.

Exclusion criteria:

  • Subjects who are receiving tenofovir.
  • Previous study participation in other experimental drug trial(s) within 30 days before the screening phase of the study.
  • Subjects who currently regularly take drugs-of-abuse, with the exception of cannabinoids.
  • Subjects who cannot refrain from taking herbal remedies during the course of the study.
  • Subjects who regularly consume more than an average amount of alcohol per day.
  • Poor general health preventing fasting or blood sampling.
  • Subjects who are not able to discontinue use of hydroxyurea, mycophenolate or ribavirin for 14 days prior to entering the study until discharge from the study.
  • An unwillingness of a male subject to abstain from sexual intercourse with women of childbearing potential or an unwillingness to use a condom in addition to having their female partner use another form of contraception.
  • The subject is pregnant or nursing an infant.
  • History of symptoms consistent with a hypersensitivity reaction to ABC.
  • Positive HCV Antibody or HepBsAg (Hepatitis B surface antigen).

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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the pharmacokinetics of intracellular CBV-TP at steady state following administration of 600 mg QD and 300 mg BID ABC-containing regimens in HIV infected adult subjects.
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
- To compare plasma concentrations of ABC, and intracellular CBV-TP - To assess the safety and tolerability of dosing with ABC 300mg BID and 600mg QD. - To assess potential gender effects in the pharmacokinetics of ABC.
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

September 1, 2005

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 15, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAL102120

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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