Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR

February 11, 2013 updated by: GlaxoSmithKline

A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.

Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • GSK Clinical Trials Call Center
      • Paris, France, 75475
        • GSK Clinical Trials Call Center
      • Paris, France, 75679
        • GSK Clinical Trials Call Center
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • GSK Clinical Trials Call Center
      • Manchester, United Kingdom, M8 6RL
        • GSK Clinical Trials Call Center
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Clinical Trials Call Center
    • California
      • Long Beach, California, United States, 90813
        • GSK Clinical Trials Call Center
      • Newport Beach, California, United States, 92663
        • GSK Clinical Trials Call Center
      • San Diego, California, United States, 92101
        • GSK Clinical Trials Call Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • GSK Clinical Trials Call Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • GSK Clinical Trials Call Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • GSK Clinical Trials Call Center
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Clinical Trials Call Center
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Clinical Trials Call Center
      • Fort Lauderdale, Florida, United States, 33334
        • GSK Clinical Trials Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • GSK Clinical Trials Call Center
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • GSK Clinical Trials Call Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL.
  • Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter.
  • Antiretroviral therapy naive (no prior therapy allowed).
  • Male or female 13 years of age or older (or 18 years of age or older according to local requirements).
  • Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex.
  • Able to understand and provide written informed consent to participate in this trial. Parental or guardian consent must also be obtained for subjects under the age of 18 years.

Exclusion Criteria:

  • Prior history of having received antiretroviral therapy.
  • An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration.
  • Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound.
  • Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration.
  • Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration.
  • Pregnant or lactating women.
  • History of clinically relevant pancreatitis or hepatitis within 6 months of study drug administration.
  • Presence of any serious medical condition (e.g., diabetes, cardiac dysfunction, hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
  • Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
  • History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study.
  • Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or anticipated need for such treatment during the study.
  • Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days of study drug administration.
  • Treatment with any HIV vaccine within 3 months of study drug administration.
  • Treatment with other selected medications within 28 days prior to receiving study medication or the anticipated need during the study.
  • Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the requirements of the study. Note: Subjects stabilized on methadone can be considered for participation.
  • Treatment with other investigational drugs or therapies within 28 days prior to Day 1, or an anticipated need for such treatment during the study. Treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis.
  • Other inclusion or exclusion criteria to be determined by the investigator and sponsor of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the overall short term tolerance of the regimens under investigation

Secondary Outcome Measures

Outcome Measure
Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

August 14, 2002

First Submitted That Met QC Criteria

August 16, 2002

First Posted (Estimate)

August 19, 2002

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZL30006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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