Status:
COMPLETED
Fosamprenavir Versus Other Protease Inhibitors
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus I
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2007
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00094523
Start Date
December 14 2004
End Date
June 29 2007
Last Update
April 18 2018
Active Locations (52)
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1
GSK Investigational Site
Beverly Hills, California, United States, 90210
2
GSK Investigational Site
Fresno, California, United States, 93720
3
GSK Investigational Site
Laguna Beach, California, United States, 90803
4
GSK Investigational Site
Long Beach, California, United States, 90813