A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
NCT ID: NCT00363142
Last Updated: 2010-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2006-05-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FPV/r200
Fosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD)
Full Boosted Fosamprenavir
Full ritonavir-boosted fosamprenavir
FPV/r100
Fosamprenavir/ritonavir 1400/100mg QD
Half-boosted Fosamprenavir
Once daily, reduced dose ritonavir-boosted fosamprenavir
Interventions
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Half-boosted Fosamprenavir
Once daily, reduced dose ritonavir-boosted fosamprenavir
Full Boosted Fosamprenavir
Full ritonavir-boosted fosamprenavir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are willing and able to understand and provide written consent prior to participation in this study.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK Clinical Disclosure
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Fountain Valley, California, United States
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Garden Grove, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Tarzana, California, United States
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West Hollywood, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Oakland Park, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Springfield, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Hillsborough, New Jersey, United States
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Somers Point, New Jersey, United States
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New York, New York, United States
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Valhalla, New York, United States
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Akron, Ohio, United States
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Allentown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Hampton, Virginia, United States
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Spokane, Washington, United States
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Ponce, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
Countries
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References
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Cohen C, Dejesus E, Lamarca A, Young B, Yau L, Patel L, Vavro C, Wire MB, Wannamaker P, Shaefer M. Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial. HIV Clin Trials. 2010 Sep-Oct;11(5):239-47. doi: 10.1310/hct1105-239.
Other Identifiers
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LEX106430
Identifier Type: -
Identifier Source: org_study_id