Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
NCT ID: NCT00365612
Last Updated: 2008-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2006-07-31
2008-01-31
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
Interventions
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Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Eligibility Criteria
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Inclusion Criteria
* Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
* HAART must consist of either:
1. A PI (with or without ritonavir) + at least 2 NRTIs or
2. An NNRTI + at least 2 NRTIs.
* Negative serum pregnancy test.
Exclusion Criteria
* Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
* Patients who are currently taking EFV+FTC+TDF.
* Patients who have a creatinine clearance of \<60 mL/min by Cockcroft-Gault estimation.
* Patients who have experienced virologic failure with any previous ARV therapy.
* Patients who have documented resistance to any of the study agents at any time in the past.
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences
Principal Investigators
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John Flaherty
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Hobson City, Alabama, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Diego, California, United States
San Francisco, California, United States
Tarzana, California, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Port Saint Lucie, Florida, United States
Safety Harbor, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Aurora, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Hillsborough, New Jersey, United States
Newark, New Jersey, United States
Newark, New Jersey, United States
Somers Point, New Jersey, United States
Albany, New York, United States
Brooklyn, New York, United States
Mount Vernon, New York, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
Annandale, Virginia, United States
Hampton, Virginia, United States
Spokane, Washington, United States
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259.
Dejesus E, Young B, Morales-Ramirez JO, Sloan L, Ward DJ, Flaherty JF, Ebrahimi R, Maa JF, Reilly K, Ecker J, McColl D, Seekins D, Farajallah A; AI266073 Study Group. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):163-74. doi: 10.1097/QAI.0b013e3181a572cf.
Related Links
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ATRIPLA website
Gilead Sciences website
Bristol-Myers Squibb website
Other Identifiers
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AI266073
Identifier Type: -
Identifier Source: org_study_id