Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen
1 other identifier
interventional
300
2 countries
56
Brief Summary
To compare the effectiveness (efficacy, safety \& tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) \<200 copies/mL at Week 48.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Jul 2006
Shorter than P25 for phase_4 hiv-infections
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 16, 2006
CompletedFirst Posted
Study publicly available on registry
August 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedApril 10, 2008
April 1, 2008
1.3 years
August 16, 2006
April 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
Safety Outcome Measures: Adverse Events, Laboratory Tests
Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 positive patients who have maintained an HIV-1 viral load \<200 copies/mL, for at least 3 months.
- 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:
- A PI (with or without ritonavir) + at least 2 NRTIs or
- An NNRTI + at least 2 NRTIs.
- Negative serum pregnancy test.
You may not qualify if:
- Patients who have taken any NNRTI prior to their current therapy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Bristol-Myers Squibbcollaborator
Study Sites (56)
Unknown Facility
Hobson City, Alabama, 36201, United States
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Phoenix, Arizona, 85006, United States
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Beverly Hills, California, 90211, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90069, United States
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Oakland, California, 94609, United States
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San Diego, California, 92103, United States
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San Francisco, California, 94114, United States
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Tarzana, California, 91356, United States
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Denver, Colorado, 80220, United States
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Norwalk, Connecticut, 06851, United States
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Washington D.C., District of Columbia, 20037, United States
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Fort Lauderdale, Florida, 33308, United States
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Hollywood, Florida, 33020, United States
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Miami, Florida, 33136, United States
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Orlando, Florida, 32803, United States
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Pensacola, Florida, 32504, United States
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Port Saint Lucie, Florida, 34952, United States
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Safety Harbor, Florida, 34695, United States
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Tampa, Florida, 33607, United States
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Vero Beach, Florida, 32960, United States
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Atlanta, Georgia, 30312, United States
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Decatur, Georgia, 30033, United States
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Aurora, Illinois, 60505, United States
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Chicago, Illinois, 60657, United States
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Indianapolis, Indiana, 46280, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02030, United States
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Springfield, Massachusetts, 01107, United States
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Berkley, Michigan, 48072, United States
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Grosse Pointe Woods, Michigan, 48236, United States
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Minneapolis, Minnesota, 55404, United States
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St Louis, Missouri, 63139, United States
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Hillsborough, New Jersey, 08844, United States
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Newark, New Jersey, 07101, United States
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Newark, New Jersey, 07102, United States
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Somers Point, New Jersey, 08244, United States
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Albany, New York, 12208, United States
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Brooklyn, New York, 11203, United States
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Mount Vernon, New York, 10550, United States
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New York, New York, 10011, United States
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Rochester, New York, 14604, United States
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Charlotte, North Carolina, 28209, United States
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Greenville, North Carolina, 27858, United States
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Winston-Salem, North Carolina, 27157, United States
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Akron, Ohio, 44304, United States
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Philadelphia, Pennsylvania, 19107, United States
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Providence, Rhode Island, 02906, United States
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Dallas, Texas, 75204, United States
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Harlingen, Texas, 78550, United States
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Houston, Texas, 77009, United States
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Annandale, Virginia, 22003, United States
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Hampton, Virginia, 23666, United States
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Spokane, Washington, 99204, United States
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Ponce, 00731, Puerto Rico
Unknown Facility
San Juan, 00909, Puerto Rico
Related Publications (2)
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.
PMID: 20156091DERIVEDDejesus 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.
PMID: 19357529DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Flaherty
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2006
First Posted
August 17, 2006
Study Start
July 1, 2006
Primary Completion
October 1, 2007
Study Completion
January 1, 2008
Last Updated
April 10, 2008
Record last verified: 2008-04