Clinical trial NCT00296504: A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Official title: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Human Immunodeficiency Virus
Keywords: antiretroviral therapy naive subjects
fosamprenavir
HIV-1
protease inhibitor
pro-drug
antiretroviral therapy
LEXIVA
AGENERASE
GW433908
amprenavir
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-27
Enrollment: 753
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Number of Participants With Any Adverse Event (AE): Interim Analysis
timeFrame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
measure: Number of Participants With Any Adverse Event (AE): Final Analysis
timeFrame: Post January 2006; for up to 241 weeks
measure: Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
timeFrame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
measure: Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
timeFrame: Weeks 120, 180, 204, 216, and 432
measure: Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
timeFrame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
measure: Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
timeFrame: Baseline (Day 1) and Weeks 48, 96, 132, and 168
measure: Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
timeFrame: Weeks 120, 180, 204, 216, and 432
measure: Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
timeFrame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
measure: Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
timeFrame: Baseline (Day 1) and Weeks 48, 96, 132, and 168
measure: Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
timeFrame: Weeks 120, 180, 204, 216, and 432
Secondary outcomes:
measure: 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)
timeFrame: Baseline and Weeks 48, 120, 180, and 216
measure: 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)
timeFrame: Baseline and Weeks 12, 24, 48, 60, 96, and 132
measure: Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
timeFrame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432
measure: Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
timeFrame: Baseline and Weeks 48, 120, 168, 180, 204, and 216
measure: Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
timeFrame: Baseline and Weeks 24, 48, 96, 132, and 168
measure: Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
timeFrame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
measure: Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
timeFrame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
measure: Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
timeFrame: Weeks 180, 240, 300, 360, 420, and 432
measure: Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
timeFrame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
measure: Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
timeFrame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
measure: Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
timeFrame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Manhasset
country: United States
facility: GSK Investigational Site
state: New York
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Le Kremlin Bicêtre Cedex
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Paris Cedex 10
country: France
facility: GSK Investigational Site
city: Paris Cedex 20
country: France
facility: GSK Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: GSK Investigational Site
city: Villejuif Cedex
country: France
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Coimbra
country: Portugal
facility: GSK Investigational Site
city: Badajoz
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: