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A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00082394
First received: May 6, 2004
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.


Condition Intervention Phase
HIV Infection
Drug: Trizivir
Drug: atazanavir
Drug: Combivir
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: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. [ Time Frame: 48 Weeks ]

Secondary Outcome Measures:
  • % patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure [ Time Frame: 48 Weeks ]

Enrollment: 280
Study Start Date: April 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Trizivir Drug: atazanavir Drug: Combivir
    Other Names:
    • Trizivir
    • atazanavir
    • Combivir
Detailed Description:

A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) BID vs Combivir (lamivudine 150mg and zidovudine 300mg) BID plus atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks

  Eligibility

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

Inclusion criteria:

  • Adults with documented HIV-1 infection.
  • Past use of HIV drugs must have been less than 15 days.
  • Plasma HIV-1 RNA between 500 and 20,000 copies/mL.
  • CD4+ cell count greater than 100 cells/mm3.
  • Willing/able to provide written informed consent.

Exclusion criteria:

  • Have AIDS at screening.
  • Pregnant or breastfeeding.
  • Underlying medical conditions considered to be significant for this protocol.
  • Participating in other investigational drug trials.
  • In the opinion of the investigator, would be unable to complete 48 weeks of dosing.
  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: NCT00082394

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Bakersfield, California, United States, 93301
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Oakland, California, United States, 94609
GSK Investigational Site
San Francisco, California, United States, 94121
United States, Colorado
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33306
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Miami Beach, Florida, United States, 33140
GSK Investigational Site
Orlando, Florida, United States, 32804
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67214
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
GSK Investigational Site
New Orleans, Louisiana, United States, 70127-0800
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63139
United States, New Jersey
GSK Investigational Site
East Orange, New Jersey, United States, 7017
GSK Investigational Site
Hillsborough, New Jersey, United States, 08876
GSK Investigational Site
Newark, New Jersey, United States, 7102
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
United States, New York
GSK Investigational Site
Mount Vernon, New York, United States, 10550
GSK Investigational Site
Valhalla, New York, United States, 10595
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Greenville, North Carolina, United States, 27858-4354
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97219
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18102
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
GSK Investigational Site
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29203
GSK Investigational Site
Greenville, South Carolina, United States, 29605
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Harlingen, Texas, United States, 78550
GSK Investigational Site
Houston, Texas, United States, 77027
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00082394     History of Changes
Other Study ID Numbers: 100327
Study First Received: May 6, 2004
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
TRIZIVIR
COMBIVIR
atazanavir
HIV
drug efficacy
safety
tolerability

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

ClinicalTrials.gov processed this record on November 20, 2014