Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365612
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : April 10, 2008
Bristol-Myers Squibb
Information provided by:
Gilead Sciences

August 16, 2006
August 17, 2006
April 10, 2008
July 2006
October 2007   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00365612 on Archive Site
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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
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2008
October 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
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John Flaherty, Director, Medical Affairs, Gilead Sciences
Gilead Sciences
Bristol-Myers Squibb
Study Director: John Flaherty Gilead Sciences
Gilead Sciences
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP