Clinical trial NCT00365612: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
HIV-1
AIDS
Human Immunodeficiency Virus
HIV-1 Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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 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.

Primary outcomes:
measure: Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
measure: Safety Outcome Measures: Adverse Events, Laboratory Tests
measure: Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Hobson City
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Beverly HIlls
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Norwalk
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Ft. Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Port St Lucie
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Berkley
country: United States
state: Michigan
city: Grosse Pointe Woods
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Hillsborough
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Mount Vernon
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Dallas
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Gilead Sciences
name: John Flaherty
role: STUDY_DIRECTOR
References:
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.
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.