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Fosamprenavir Versus Other Protease Inhibitors

Primary Purpose

Infection, Human Immunodeficiency Virus I

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fosamprenavir
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus I focused on measuring fosamprenavir LEXIVA non-inferiority safety tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be on your first protease inhibitor (PI) containing regimen, and the regimen must consist of a PI +/- ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (N[t]RTIs). Have a plasma HIV-1 RNA level (viral load) at screening of less than 400 copies/mL, for at least 3 months prior to Screening and at Screening while on your current regimen of a PI +/- ritonavir + 2 N(t)RTIs. Females must not be pregnant or breastfeeding or plan to become pregnant during the study. Females of child-bearing potential must agree to use one of the approved methods of birth control. Exclusion Criteria: Not able to follow the medication schedules and attend the study visits for the entire length of the study. Have any other illnesses, laboratory test results, medication use, allergies, or medical conditions that would make it unsafe for the subject to participate in this study. Currently be enrolled in any other research studies that could affect the subject''''s HIV-1 RNA levels.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm A

Treatment Arm B

Arm Description

Subjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks.

Subjects continued baseline regimen for first 24 weeks with the option of switching their initial PI for fosamprenavir (± ritonavir) while maintaining their baseline nucleoside or nucleotide reverse transcriptase inhibitor regimen for another 24 weeks

Outcomes

Primary Outcome Measures

Percentage of subjects with HIV-1 RNA less than 400 copies/mL

Secondary Outcome Measures

Percentage of subjects with plasma HIV-1 RNA <400 copies/mL
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48
Number of subjects with any adverse events (AEs)
Number of subjects with gastrointestinal (GI) AEs
Absolute values of plasma HIV-1 RNA at Week 24
Median change from Baseline in HIV-1 RNA at Week 24
Absolute values of plasma HIV-1 RNA at Week 48
Median change from Baseline in HIV-1 RNA at Week 48
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Number of subjects with genotypic resistance at virologic failure
Number of subjects with phenotypic resistance at virologic failure
Time to loss of virologic response (TLOVR)
Medication adherence at Week 24
Medication adherence at Week 48
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48

Full Information

First Posted
October 20, 2004
Last Updated
April 16, 2018
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00094523
Brief Title
Fosamprenavir Versus Other Protease Inhibitors
Official Title
A Phase IIIB/IV, Open-label, Multi-center Trial to Evaluate the Safety, Tolerability, and Efficiency of HIV-1 Infected Subjects Switching Their Current Protease-inhibitor Therapies for a Fosamprenavir Therapy Over 48 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 14, 2004 (Actual)
Primary Completion Date
June 29, 2007 (Actual)
Study Completion Date
June 29, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was designed to evaluate and compare safety, tolerability of subjects who successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir. This is a 48-week study, where subjects who were assigned to be in their original PI-group have the option of switching to fosamprenavir on week 24. Prior to being assigned their treatment group, subjects had to be suppressed for at least three months. All subjects also take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus I
Keywords
fosamprenavir LEXIVA non-inferiority safety tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A
Arm Type
Experimental
Arm Description
Subjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks.
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm Description
Subjects continued baseline regimen for first 24 weeks with the option of switching their initial PI for fosamprenavir (± ritonavir) while maintaining their baseline nucleoside or nucleotide reverse transcriptase inhibitor regimen for another 24 weeks
Intervention Type
Drug
Intervention Name(s)
Fosamprenavir
Intervention Description
Fosamprenavir
Primary Outcome Measure Information:
Title
Percentage of subjects with HIV-1 RNA less than 400 copies/mL
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of subjects with plasma HIV-1 RNA <400 copies/mL
Time Frame
Week 48
Title
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24
Time Frame
Week 24
Title
Percentage of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48
Time Frame
Week 48
Title
Number of subjects with any adverse events (AEs)
Time Frame
up to Week 48
Title
Number of subjects with gastrointestinal (GI) AEs
Time Frame
up to Week 48
Title
Absolute values of plasma HIV-1 RNA at Week 24
Time Frame
Week 24
Title
Median change from Baseline in HIV-1 RNA at Week 24
Time Frame
Baseline and Week 24
Title
Absolute values of plasma HIV-1 RNA at Week 48
Time Frame
Week 48
Title
Median change from Baseline in HIV-1 RNA at Week 48
Time Frame
Baseline and Week 48
Title
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Time Frame
Week 24
Title
Absolute values in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Time Frame
Week 48
Title
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Time Frame
Baseline and Week 24
Title
Median change from Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
Time Frame
Baseline and Week 48
Title
Number of subjects with genotypic resistance at virologic failure
Time Frame
up to Week 48
Title
Number of subjects with phenotypic resistance at virologic failure
Time Frame
up to Week 48
Title
Time to loss of virologic response (TLOVR)
Time Frame
up to Week 48
Title
Medication adherence at Week 24
Time Frame
Week 24
Title
Medication adherence at Week 48
Time Frame
Week 48
Title
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 24
Time Frame
Week 24
Title
Subject treatment satisfaction per the HIV Treatment Satisfaction Questionnaire at Week 48
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be on your first protease inhibitor (PI) containing regimen, and the regimen must consist of a PI +/- ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (N[t]RTIs). Have a plasma HIV-1 RNA level (viral load) at screening of less than 400 copies/mL, for at least 3 months prior to Screening and at Screening while on your current regimen of a PI +/- ritonavir + 2 N(t)RTIs. Females must not be pregnant or breastfeeding or plan to become pregnant during the study. Females of child-bearing potential must agree to use one of the approved methods of birth control. Exclusion Criteria: Not able to follow the medication schedules and attend the study visits for the entire length of the study. Have any other illnesses, laboratory test results, medication use, allergies, or medical conditions that would make it unsafe for the subject to participate in this study. Currently be enrolled in any other research studies that could affect the subject''''s HIV-1 RNA levels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Laguna Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
GSK Investigational Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
GSK Investigational Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
GSK Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
GSK Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
GSK Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1426
Country
United States
Facility Name
GSK Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
GSK Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
GSK Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
GSK Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
GSK Investigational Site
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
GSK Investigational Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
GSK Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14604
Country
United States
Facility Name
GSK Investigational Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
GSK Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
GSK Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74129
Country
United States
Facility Name
GSK Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206-4713
Country
United States
Facility Name
GSK Investigational Site
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
GSK Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75604
Country
United States
Facility Name
GSK Investigational Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
GSK Investigational Site
City
Ponce
ZIP/Postal Code
731
Country
Puerto Rico

12. IPD Sharing Statement

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Fosamprenavir Versus Other Protease Inhibitors

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