A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination
NCT00335270 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2013-05-14
Summary
The purpose of this study is to evaluate the antiretroviral efficacy, safety, and tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when administered in combination with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults
Conditions
Interventions
- DRUG
-
fos-amprenavir calcium, ritonavir
- DRUG
-
abacavir/lamivudine as Epzicom
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Charles Hicks, MD · Duke University
-
Rafael E Campo, MD · University of Miami
-
Jason Flamm, MD · Medicine 4
-
Jeffrey Lennox, MD · Emory University
-
Rodger MacArthur, MD · Wayne State University
-
Jeffrey P Nadler, MD · Hillsborough County Health Department
-
John H. Schrank, MD · Greenville Hospital System
-
Louis Sloan, MD · North Texas Infectious Disease Consultants
-
Jeffrey Stephens, MD · Mercer University School of Medicine
-
David A Wohl, MD · University of North Carolina, Chapel Hill
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2007-12-31
- Completion
- 2007-12-31
Countries
- United States
Study Locations
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