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

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296504
• Other study ID #: APV30005
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2006
• Last updated: April 11, 2013
• Start date: November 2001
• Est. completion date: October 2010

Study information

• Verified date: June 2012
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 753
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• fosamprenavir (GW433908)

• ritonavir

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Campinas	São Paulo
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
France	GSK Investigational Site	Le Kremlin Bicêtre Cedex
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris Cedex 20
France	GSK Investigational Site	Vandoeuvre Les Nancy Cedex
France	GSK Investigational Site	Villejuif Cedex
Italy	GSK Investigational Site	Genova	Liguria
Portugal	GSK Investigational Site	Coimbra
Spain	GSK Investigational Site	Badajoz
Spain	GSK Investigational Site	Barcelona
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Manhasset	New York
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Brazil,  Chile,  France,  Italy,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Adverse Event (AE): Interim Analysis	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.	Baseline (Day 1) up to 31 January 2006 (up to Week 264)	No
Primary	Number of Participants With Any Adverse Event (AE): Final Analysis	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.	Post January 2006; for up to 241 weeks	No
Primary	Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216	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).	Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216	No
Primary	Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432	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).	Weeks 120, 180, 204, 216, and 432	No
Primary	Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216	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).	Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216	No
Primary	Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168	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).	Baseline (Day 1) and Weeks 48, 96, 132, and 168	No
Primary	Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432	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.	Weeks 120, 180, 204, 216, and 432	No
Primary	Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216	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).	Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216	No
Primary	Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168	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).	Baseline (Day 1) and Weeks 48, 96, 132, and 168	No
Primary	Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432	Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.	Weeks 120, 180, 204, 216, and 432	No
Secondary	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)	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.	Baseline and Weeks 48, 120, 180, and 216	No
Secondary	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)	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.	Baseline and Weeks 12, 24, 48, 60, 96, and 132	No
Secondary	Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)	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.	Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432	No
Secondary	Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis	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.	Baseline and Weeks 48, 120, 168, 180, 204, and 216	No
Secondary	Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis	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.	Baseline and Weeks 24, 48, 96, 132, and 168	No
Secondary	Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216	Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.	Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216	No
Secondary	Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168	Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.	Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168	No
Secondary	Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432	Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.	Weeks 180, 240, 300, 360, 420, and 432	No
Secondary	Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline	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.	Baseline (Day 1) up to 31 January 2006 (up to Week 264)	No
Secondary	Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions	The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.	Baseline (Day 1) up to 31 January 2006 (up to Week 264)	No
Secondary	Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions	The number of participants with the indicated HIV-associated conditions were assessed.	Baseline (Day 1) up to 31 January 2006 (up to Week 264)	No