Fosamprenavir Versus Other Protease Inhibitors

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00094523
First received: October 20, 2004
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus I Infection
HIV Infection
Drug: fosamprenavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects with HIV-1 RNA less than 400 copies/mL [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • % subjects with HIV-1 RNA <400 copies/mL [ Time Frame: week 48 ]
  • % subjects with HIV-1 RNA <50 copies/mL AEs CD4 and HIV-1 RNA [ Time Frame: weeks 24 and 48 ]
  • Adherence to study medications [ Time Frame: Throughout study ]

Enrollment: 312
Study Start Date: December 2004
Study Completion Date: June 2007
Intervention Details:
    Drug: fosamprenavir
    Other Name: fosamprenavir
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094523

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
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
Tarzana, California, United States, 30342
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33306
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Hollywood, Florida, United States, 33020
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
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
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
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74129
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29206-4713
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Dallas, Texas, United States, 75246
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
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 731
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00094523     History of Changes
Other Study ID Numbers: 100290
Study First Received: October 20, 2004
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
fosamprenavir LEXIVA non-inferiority safety tolerability

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Protease Inhibitors
Fosamprenavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014