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Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00038506
First received: May 31, 2002
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.


Condition Intervention Phase
HIV Infection
 Drug: abacavir/lamivudine/zidovudine
Drug: tenofovir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes [ Time Frame: 24 weeks ]

Estimated Enrollment: 100
Study Start Date: March 2002
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: abacavir/lamivudine/zidovudine Drug: tenofovir
    Other Names:
    • abacavir/lamivudine/zidovudine
    • tenofovir
  Eligibility

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

Inclusion Criteria:

  • Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
  • Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
  • Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
  • A CD4+ lymphocyte count less than or equal to 100.

Exclusion Criteria:

  • Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
  • Have not had an AIDS defining illness within 30 days of screen.
  • Pregnant or breast-feeding.
  • Specified viral genotypes upon screening.
  • And other inclusion or exclusion criteria to be evaluated by the physician.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038506

Locations
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90027
GSK Investigational Site
San Rafael, California, United States, 94903
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Jacksonville, Florida, United States, 32206
GSK Investigational Site
Lake Worth, Florida, United States, 33463
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Miami Beach, Florida, United States, 33139
GSK Investigational Site
North Miami, Florida, United States, 33161
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Tallahassee, Florida, United States, 32303
United States, Georgia
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
GSK Investigational Site
Maywood, Illinois, United States, 60153
United States, Indiana
GSK Investigational Site
Lafayette, Indiana, United States, 47904
United States, Michigan
GSK Investigational Site
Berkeley, Michigan, United States, 48072
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
New York, New York, United States, 10014
GSK Investigational Site
Valhalla, New York, United States, 10595
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74114
United States, Texas
GSK Investigational Site
Arlington, Texas, United States, 76015
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75216
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Houston, Texas, United States, 77004
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104
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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00038506     History of Changes
Other Study ID Numbers: ESS 30005
Study First Received: May 31, 2002
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1 TRIZIVIR 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
Zidovudine
Lamivudine
Tenofovir
 Tenofovir disoproxil
Abacavir
Lamivudine, zidovudine drug combination
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013