Fosamprenavir Versus Other Protease Inhibitors

NCT00094523 | Completed Phase 3

• 1 other identifier: 100290
• Study Type: interventional
• Target: 314
• Locations: 2 countries
• Sites: 52

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.

Conditions

Infection, Human Immunodeficiency Virus I

Keywords

fosamprenavir LEXIVA non-inferiority safety tolerability

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (20)

• 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

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

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

Treatment Arm B

EXPERIMENTAL

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

Interventions

Fosamprenavir DRUG

Fosamprenavir

Treatment Arm A; Treatment Arm B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (52)

GSK Investigational Site

Beverly Hills, California, 90210, United States

Location

GSK Investigational Site

Fresno, California, 93720, United States

Location

GSK Investigational Site

Laguna Beach, California, 90803, United States

Location

GSK Investigational Site

Long Beach, California, 90813, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

Tarzana, California, 91356, United States

Location

GSK Investigational Site

Denver, Colorado, 80220, United States

Location

GSK Investigational Site

Fort Collins, Colorado, 80528, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33145, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33306, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33901, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32206, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33408, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30339, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Des Moines, Iowa, 50309-1426, United States

Location

GSK Investigational Site

Wichita, Kansas, 67214, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40536, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70121, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71103, United States

Location

GSK Investigational Site

Detroit, Michigan, 48202, United States

Location

GSK Investigational Site

Jackson, Mississippi, 39202, United States

Location

GSK Investigational Site

Hillsborough, New Jersey, 08844, United States

Location

GSK Investigational Site

Somers Point, New Jersey, 08244, United States

Location

GSK Investigational Site

Brooklyn, New York, 11212, United States

Location

GSK Investigational Site

New York, New York, 10014, United States

Location

GSK Investigational Site

Rochester, New York, 14604, United States

Location

GSK Investigational Site

Valhalla, New York, 10595, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28211, United States

Location

GSK Investigational Site

Akron, Ohio, 44304, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74129, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18103, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29206-4713, United States

Location

GSK Investigational Site

Morristown, Tennessee, 37813, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Houston, Texas, 77098, United States

Location

GSK Investigational Site

Longview, Texas, 75604, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Ponce, 731, Puerto Rico

Location

MeSH Terms

Conditions

Infections

Interventions

fosamprenavir

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2004
• First Posted: October 21, 2004
• Study Start: December 14, 2004
• Primary Completion: June 29, 2007
• Study Completion: June 29, 2007
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

PR (1); US (51)