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

NCT00296504 | Completed Phase 3 Results

• 1 other identifier: APV30005
• Study Type: interventional
• Target: 753
• Locations: 8 countries
• Sites: 24

Brief 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.

Conditions

Infection, Human Immunodeficiency Virus

Keywords

antiretroviral therapy naive subjects; fosamprenavir; HIV-1; protease inhibitor; pro-drug; antiretroviral therapy; LEXIVA; AGENERASE; GW433908; amprenavir

Outcome Measures

Primary Outcomes (10)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (11)

• 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)

  Baseline and Weeks 48, 120, 180, and 216

• 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)

  Baseline and Weeks 12, 24, 48, 60, 96, and 132

• Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)

  Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432

• Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis

  Baseline and Weeks 48, 120, 168, 180, 204, and 216

• Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis

  Baseline and Weeks 24, 48, 96, 132, and 168

Interventions

fosamprenavir (GW433908) DRUG

ritonavir DRUG

Also known as: fosamprenavir (GW433908)

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (24)

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

San Francisco, California, 94115-1931, United States

Location

GSK Investigational Site

Denver, Colorado, 80262, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33145, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Sarasota, Florida, 34239, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

Manhasset, New York, 11030, United States

Location

GSK Investigational Site

Galveston, Texas, 77555-1188, United States

Location

GSK Investigational Site

Campinas, São Paulo, 13083970, Brazil

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

GSK Investigational Site

Marseille, 13005, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Paris, 75970, France

Location

GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Genoa, Liguria, 16128, Italy

Location

GSK Investigational Site

Coimbra, 3000-075, Portugal

Location

GSK Investigational Site

Badajoz, 6080, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

fosamprenavir; Ritonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: ViiV Healthcare

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 27, 2006
• Study Start: November 1, 2001
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 19, 2013
• Results First Posted: November 8, 2011

Record last verified: 2012-06

Locations

US (10); PT (1); ES (2); GB (2); IT (1); FR (6); BR (1); CL (1)