A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00296504
First received: February 24, 2006
Last updated: April 11, 2013
Last verified: June 2012
  Purpose

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: fosamprenavir (GW433908)
Drug: ritonavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Number of Participants With Any Adverse Event (AE): Interim Analysis [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.

  • Number of Participants With Any Adverse Event (AE): Final Analysis [ Time Frame: Post January 2006; for up to 241 weeks ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.

  • Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216 ] [ Designated as safety issue: No ]
    Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  • Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 [ Time Frame: Weeks 120, 180, 204, 216, and 432 ] [ Designated as safety issue: No ]
    Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).

  • Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 [ Time Frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 ] [ Designated as safety issue: No ]
    blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  • Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168 ] [ Designated as safety issue: No ]
    Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  • Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 [ Time Frame: Weeks 120, 180, 204, 216, and 432 ] [ Designated as safety issue: No ]
    Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.

  • Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 [ Time Frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  • Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).

  • Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 [ Time Frame: Weeks 120, 180, 204, 216, and 432 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.


Secondary Outcome Measures:
  • Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) [ Time Frame: Baseline and Weeks 48, 120, 180, and 216 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.

  • Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) [ Time Frame: Baseline and Weeks 12, 24, 48, 60, 96, and 132 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.

  • Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) [ Time Frame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.

  • Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis [ Time Frame: Baseline and Weeks 48, 120, 168, 180, 204, and 216 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.

  • Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis [ Time Frame: Baseline and Weeks 24, 48, 96, 132, and 168 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.

  • Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 [ Time Frame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  • Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 [ Time Frame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  • Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 [ Time Frame: Weeks 180, 240, 300, 360, 420, and 432 ] [ Designated as safety issue: No ]
    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  • Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ] [ Designated as safety issue: No ]
    The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.

  • Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ] [ Designated as safety issue: No ]
    The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.

  • Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ] [ Designated as safety issue: No ]
    The number of participants with the indicated HIV-associated conditions were assessed.


Enrollment: 753
Study Start Date: November 2001
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fosamprenavir (GW433908) Drug: ritonavir
    Other Names:
    • fosamprenavir (GW433908)
    • ritonavir
Detailed Description:

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

  Eligibility

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

Inclusion Criteria:

  • Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
  • Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Exclusion Criteria:

  • Permanent discontinuation of GW433908 in a previous study due to intolerance.
  • An active CDC Class C Event.
  • Any condition which, in the opinion of the investigator, would preclude a subject from participation.
  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: NCT00296504

Locations
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
San Francisco, California, United States, 94115-1931
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80262
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Sarasota, Florida, United States, 34239
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, New York
GSK Investigational Site
Manhasset, New York, United States, 11030
United States, Texas
GSK Investigational Site
Galveston, Texas, United States, 77555-1188
Brazil
GSK Investigational Site
Campinas, São Paulo, Brazil, 13083970
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
France
GSK Investigational Site
Le Kremlin Bicêtre Cedex, France, 94275
GSK Investigational Site
Marseille, France, 13005
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris Cedex 20, France, 75970
GSK Investigational Site
Vandoeuvre Les Nancy Cedex, France, 54511
GSK Investigational Site
Villejuif Cedex, France, 94805
Italy
GSK Investigational Site
Genova, Liguria, Italy, 16128
Portugal
GSK Investigational Site
Coimbra, Portugal, 3000-075
Spain
GSK Investigational Site
Badajoz, Spain, 6080
GSK Investigational Site
Barcelona, Spain, 08036
United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 7EH
GSK Investigational Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00296504     History of Changes
Other Study ID Numbers: APV30005
Study First Received: February 24, 2006
Results First Received: September 30, 2011
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by ViiV Healthcare:
antiretroviral therapy naive subjects
fosamprenavir
HIV-1
protease inhibitor
pro-drug
antiretroviral therapy
LEXIVA
AGENERASE
GW433908
amprenavir

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

ClinicalTrials.gov processed this record on July 22, 2014