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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320307
First Posted: May 3, 2006
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
May 1, 2006
May 3, 2006
October 16, 2008
September 2005
Not Provided
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 ]
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 HIVinfected adult subjects.
Complete list of historical versions of study NCT00320307 on ClinicalTrials.gov Archive Site
- 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 ]
- 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.
Not Provided
Not Provided
 
Comparison of Abacavir Following Once-Daily And Twice-Daily Administration In HIV Infected Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
Drug: abacavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00320307
CAL102120
Not Provided
Not Provided
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP