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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00320307
First received: May 1, 2006
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  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 body’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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
Intervention Details:
    Drug: abacavir
    Other Name: abacavir
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Human Immunodeficiency Virus
HIV
Abacavir regime
ABC

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Abacavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013