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OpenTrials
Completed

NCT Number: NCT00320307

Comparison of Abacavir Following Once-Daily And Twice-Daily Administration 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.

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Key information

Conditions

HIV Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, SW10 9TH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Abacavir

Drug

Primary outcomes

  1. 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 outcomes

  1. - 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2005
First posted
May 3, 2006
Registry last updated
Oct 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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