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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
GlaxoSmithKline


Information provided by (Responsible Party)
GlaxoSmithKline
ClinicalTrials.gov Identifier
NCT00320307

First received: May 1, 2006
Last updated: October 15, 2008
Last Verified: October 2008
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infection

Drug : abacavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Further study details as provided by GlaxoSmithKline:

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. [ Time Frame: throughout the study ]
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. [ Time Frame: throughout the study ]

Enrollment: 30
Study Start Date: September 2005

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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).

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320307

Locations

United Kingdom
GSK Investigational Site
London, United Kingdom, SW10 9TH

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

More Information


Responsible Party: Study Director, GSK  
ClinicalTrials.gov Identifier: NCT00320307   History of Changes  
Other Study ID Numbers: CAL102120  
Study First Received: May 1, 2006  
Last Updated: October 15, 2008  

Keywords provided by GlaxoSmithKline:

Human Immunodeficiency Virus
HIV
Abacavir regime
ABC

Additional relevant MeSH terms:
HIV Infections
Abacavir
Dideoxynucleosides

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.