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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection

Keywords

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Human Immunodeficiency Virus HIV Abacavir regime ABC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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abacavir

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CAL102120

Identifier Type: -

Identifier Source: org_study_id