Status:
COMPLETED
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infection
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered ei...
Detailed Description
A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with HIV-1 infection.
- Are willing and able to understand and provide written consent prior to participation in this study.
- Exclusion criteria:
- Are pregnant or breastfeeding.
- Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
- Have certain medical conditions that may make participation unsafe.
- Take medication that may interact with the study medication.
- Have a history of allergy to any of the study drugs or any excipients therein.
- Other inclusion/exclusion criteria to be evaluated by the physician.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00363142
Start Date
May 1 2006
End Date
June 1 2008
Last Update
November 5 2010
Active Locations (51)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85006
2
GSK Investigational Site
Little Rock, Arkansas, United States, 72207
3
GSK Investigational Site
Beverly Hills, California, United States, 90211
4
GSK Investigational Site
Fountain Valley, California, United States, 92708