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

NCT00320307 | Completed Phase 1

• 1 other identifier: CAL102120
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

Human Immunodeficiency Virus; HIV; Abacavir regime; ABC

Outcome Measures

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.

  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.

  throughout the study

Interventions

abacavir DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

abacavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: September 1, 2005
• Last Updated: October 16, 2008

Record last verified: 2008-10

Locations

GB (1)