A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00053638
First received: February 4, 2003
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.


Condition Intervention Phase
HIV Infection
Drug: efavirenz
Drug: tenofovir
Drug: abacavir/lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Viral load response at 48 weeks [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics [ Time Frame: 48 weeks ]

Estimated Enrollment: 345
Study Start Date: February 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: efavirenz Drug: tenofovir Drug: abacavir/lamivudine
    Other Names:
    • efavirenz
    • tenofovir
    • abacavir/lamivudine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participants must be able to provide informed consent.
  • Have documented HIV-1 infection.
  • Have not received more than 14 days of prior treatment with antiretroviral drugs.
  • Meet laboratory test criteria.
  • Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
  • Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

  • Enrolled in other HIV treatment studies.
  • Pregnant or breastfeeding.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053638

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
San Francisco, California, United States, 94115-1931
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80205
GSK Investigational Site
Denver, Colorado, United States, 80220
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007-2113
GSK Investigational Site
Washington, District of Columbia, United States, 20009
GSK Investigational Site
Washington, District of Columbia, United States, 20036
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Jacksonville, Florida, United States, 32206
GSK Investigational Site
Miami, Florida, United States, 33133
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
North Miami, Florida, United States, 33161
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Tampa, Florida, United States, 33602
GSK Investigational Site
Vero Beach, Florida, United States, 32960
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Atlanta, Georgia, United States, 30309
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202 - 5124
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67214
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70127-0800
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
GSK Investigational Site
Albany, New York, United States, 12208
GSK Investigational Site
Buffalo, New York, United States, 14215
GSK Investigational Site
New York, New York, United States, 10014
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
Stony Brook, New York, United States, 11794
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45267-0405
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
GSK Investigational Site
Portland, Oregon, United States, 97219
United States, Pennsylvania
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
GSK Investigational Site
Reading, Pennsylvania, United States, 19601
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29206-4713
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Tyler, Texas, United States, 75708
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
GSK Investigational Site
Lynchburg, Virginia, United States, 24501
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
GSK Investigational Site
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00053638     History of Changes
Other Study ID Numbers: ESS30009
Study First Received: February 4, 2003
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1 Efavirenz Tenofovir

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
Lamivudine
Efavirenz
Abacavir
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 September 16, 2014