Fosamprenavir Versus Other Protease Inhibitors

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

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.

Study Overview

• Status: Completed
• Conditions: Infection, Human Immunodeficiency Virus I
• Intervention / Treatment: Drug: Fosamprenavir

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 731
    • GSK Investigational Site
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • GSK Investigational Site
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Laguna Beach, California, United States, 90803
      • GSK Investigational Site
    • Long Beach, California, United States, 90813
      • GSK Investigational Site
    • Los Angeles, California, United States, 90069
      • GSK Investigational Site
    • Tarzana, California, United States, 91356
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80220
      • GSK Investigational Site
    • Fort Collins, Colorado, United States, 80528
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GSK Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33306
      • GSK Investigational Site
    • Fort Lauderdale, Florida, United States, 33308
      • GSK Investigational Site
    • Fort Lauderdale, Florida, United States, 33145
      • GSK Investigational Site
    • Fort Myers, Florida, United States, 33901
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32206
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Orlando, Florida, United States, 32804
      • GSK Investigational Site
    • Plantation, Florida, United States, 33317
      • GSK Investigational Site
    • Tampa, Florida, United States, 33614
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33408
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • GSK Investigational Site
    • Augusta, Georgia, United States, 30912
      • GSK Investigational Site
  • Iowa
    • Des Moines, Iowa, United States, 50309-1426
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40202
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • GSK Investigational Site
    • New Orleans, Louisiana, United States, 70121
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71103
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • GSK Investigational Site
    • Somers Point, New Jersey, United States, 08244
      • GSK Investigational Site
  • New York
    • Brooklyn, New York, United States, 11212
      • GSK Investigational Site
    • New York, New York, United States, 10014
      • GSK Investigational Site
    • Rochester, New York, United States, 14604
      • GSK Investigational Site
    • Valhalla, New York, United States, 10595
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28211
      • GSK Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44304
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
    • Tulsa, Oklahoma, United States, 74129
      • GSK Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • GSK Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29206-4713
      • GSK Investigational Site
  • Tennessee
    • Morristown, Tennessee, United States, 37813
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75208
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77027
      • GSK Investigational Site
    • Houston, Texas, United States, 77098
      • GSK Investigational Site
    • Longview, Texas, United States, 75604
      • GSK Investigational Site
  • Virginia
    • Hampton, Virginia, United States, 23666
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm A; Subjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks.	Drug: Fosamprenavir; Fosamprenavir
Experimental: Treatment Arm B; 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	Drug: Fosamprenavir; Fosamprenavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with HIV-1 RNA less than 400 copies/mL	Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2004
• Primary Completion (Actual): June 29, 2007
• Study Completion (Actual): June 29, 2007

Study Registration Dates

• First Submitted: October 20, 2004
• First Submitted That Met QC Criteria: October 20, 2004
• First Posted (Estimate): October 21, 2004

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: fosamprenavir LEXIVA non-inferiority safety tolerability
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Fosamprenavir
• Other Study ID Numbers: 100290