Comparison of Abacavir Following Once-Daily And Twice-Dai... | NCT00320307

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

NCT00320307

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

HIV Infection

Interventions

abacavir

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 1, 2006

First Submission Date that Met QC Criteria

May 1, 2006

First Posted Date

May 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
abacavir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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.		throughout the study

Secondary Outcomes

Measure	Description	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.		throughout the study

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		London		SW10 9TH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided