Back to resultsSingle Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, HIV-1, AIDS, Human Immunodeficiency Virus, HIV-1 Infection
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00365612
First Posted
August 16, 2006
Last Updated
April 9, 2008
Sponsor
Gilead Sciences
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00365612
Brief Title
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, HIV-1, AIDS, Human Immunodeficiency Virus, HIV-1 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Primary Outcome Measure Information:
Title
Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
Title
Safety Outcome Measures: Adverse Events, Laboratory Tests
Title
Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Flaherty
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Hobson City
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Beverly HIlls
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
City
Port St Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60505
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02030
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Mount Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14604
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20156091
Citation
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.
Results Reference
derived
PubMed Identifier
19357529
Citation
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.
Results Reference
derived
Links:
URL
http://www.atripla.com
Description
ATRIPLA website
URL
http://www.Gilead.com
Description
Gilead Sciences website
URL
http://www.BMS.com
Description
Bristol-Myers Squibb website
Learn more about this trial
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
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