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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00365612
First received: August 16, 2006
Last updated: April 9, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
HIV Infections
Drug: Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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

Estimated Enrollment: 300
Study Start Date: July 2006
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365612

  Hide Study Locations
Locations
United States, Alabama
Hobson City, Alabama, United States, 36201
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, California
Beverly HIlls, California, United States, 90211
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90069
Oakland, California, United States, 94609
San Diego, California, United States, 92103
San Francisco, California, United States, 94114
Tarzana, California, United States, 91356
United States, Colorado
Denver, Colorado, United States, 80220
United States, Connecticut
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Ft. Lauderdale, Florida, United States, 33308
Hollywood, Florida, United States, 33020
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
Pensacola, Florida, United States, 32504
Port St Lucie, Florida, United States, 34952
Safety Harbor, Florida, United States, 34695
Tampa, Florida, United States, 33607
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30312
Decatur, Georgia, United States, 30033
United States, Illinois
Aurora, Illinois, United States, 60505
Chicago, Illinois, United States, 60657
United States, Indiana
Indianapolis, Indiana, United States, 46280
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02030
Springfield, Massachusetts, United States, 01107
United States, Michigan
Berkley, Michigan, United States, 48072
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Missouri
St. Louis, Missouri, United States, 63139
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
Newark, New Jersey, United States, 07102
Newark, New Jersey, United States, 07101
Somers Point, New Jersey, United States, 08244
United States, New York
Albany, New York, United States, 12208
Brooklyn, New York, United States, 11203
Mount Vernon, New York, United States, 10550
New York, New York, United States, 10011
Rochester, New York, United States, 14604
United States, North Carolina
Charlotte, North Carolina, United States, 28209
Greenville, North Carolina, United States, 27858
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron, Ohio, United States, 44304
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Texas
Dallas, Texas, United States, 75204
Harlingen, Texas, United States, 78550
Houston, Texas, United States, 77009
United States, Virginia
Annandale, Virginia, United States, 22003
Hampton, Virginia, United States, 23666
United States, Washington
Spokane, Washington, United States, 99204
Puerto Rico
Ponce, Puerto Rico, 00731
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Gilead Sciences
Bristol-Myers Squibb
Investigators
Study Director: John Flaherty Gilead Sciences
  More Information

Additional Information:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Flaherty, Director, Medical Affairs, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00365612     History of Changes
Other Study ID Numbers: AI266073
Study First Received: August 16, 2006
Last Updated: April 9, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Gilead Sciences:
HIV
HIV-1
AIDS
Human Immunodeficiency Virus
HIV-1 Infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 15, 2014