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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

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
  2. Safety Outcome Measures: Adverse Events, Laboratory Tests
  3. Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00365612

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Sponsors and Collaborators
Gilead Sciences
Bristol-Myers Squibb
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Study Director: John Flaherty Gilead Sciences
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: John Flaherty, Director, Medical Affairs, Gilead Sciences Identifier: NCT00365612    
Other Study ID Numbers: AI266073
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008
Keywords provided by Gilead Sciences:
Human Immunodeficiency Virus
HIV-1 Infection
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers