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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043888
First received: August 14, 2002
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: fosamprenavir
Drug: COMBIVIR
Drug: ritonavir
Drug: TRIZIVIR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the overall short term tolerance of the regimens under investigation

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 60
Study Start Date: January 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043888

Locations
United States, Arkansas
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72205
United States, California
GSK Clinical Trials Call Center
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
United States, Colorado
GSK Clinical Trials Call Center
Denver, Colorado, United States, 80220
United States, District of Columbia
GSK Clinical Trials Call Center
Washington, District of Columbia, United States, 20036
United States, Florida
GSK Clinical Trials Call Center
Altamonte Springs, Florida, United States, 32701
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States, 33316
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States, 33308
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States, 33334
United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30339
United States, North Carolina
GSK Clinical Trials Call Center
Greenville, North Carolina, United States, 27858
United States, Pennsylvania
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, United States, 19107
France
GSK Clinical Trials Call Center
Lyon, France, 69437
GSK Clinical Trials Call Center
Paris, France, 75679
GSK Clinical Trials Call Center
Paris, France, 75475
United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom, SE5 9RS
GSK Clinical Trials Call Center
Manchester, United Kingdom, M8 6RL
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00043888     History of Changes
Other Study ID Numbers: AZL30006
Study First Received: August 14, 2002
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
fosamprenavir
ritonavir
COMBIVIR
TRIZIVIR
abacavir
lamivudine
zidovudine
HIV
protease inhibitors

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
Zidovudine
Lamivudine, zidovudine drug combination
Ritonavir
Fosamprenavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014