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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

abacavir

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Human Immunodeficiency Virus, HIV, Abacavir regime, ABC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

GSK Investigational Site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

- 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.

Full Information

NCT ID

NCT00320307

First Posted

May 1, 2006

Last Updated

October 15, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00320307

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

Human Immunodeficiency Virus, HIV, Abacavir regime, ABC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

abacavir

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

- 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials, MD

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SW10 9TH

Country

United Kingdom

HIV Infection

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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