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



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/25/2017
Start Date:April 26, 2004
End Date:March 1, 2006

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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

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.
We found this trial at
39
sites
GSK Investigational Site
Dallas, Texas 75230
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Dallas, TX
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GSK Investigational Site
Akron, Ohio 44313
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Akron, OH
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GSK Investigational Site
Allentown, Pennsylvania 18102
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Allentown, PA
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GSK Investigational Site
Atlanta, Georgia 30341
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Atlanta, GA
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GSK Investigational Site
Austin, Texas 78705
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Austin, TX
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GSK Investigational Site
Bakersfield, California 93309
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Bakersfield, CA
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GSK Investigational Site
Charlotte, North Carolina 28203
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Charlotte, NC
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GSK Investigational Site
Chicago, Illinois 60611
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Chicago, IL
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GSK Investigational Site
Columbia, South Carolina 29203
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Columbia, SC
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GSK Investigational Site
Decatur, Georgia 30033
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Decatur, GA
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GSK Investigational Site
East Orange, New Jersey
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East Orange, NJ
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GSK Investigational Site
Fort Collins, Colorado 80528
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Fort Collins, CO
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GSK Investigational Site
Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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GSK Investigational Site
Fort Myers, Florida 33916
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Fort Myers, FL
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GSK Investigational Site
Greenville, North Carolina 27858
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Greenville, NC
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GSK Investigational Site
Greenville, South Carolina 29615
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Greenville, SC
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GSK Investigational Site
Guadalajara, Jalisco 44340
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Guadalajara,
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GSK Investigational Site
Hampton, Virginia 23666
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Hampton, VA
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GSK Investigational Site
Harlingen, Texas 78550
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Harlingen, TX
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GSK Investigational Site
Hillsborough, New Jersey 08844
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Hillsborough, NJ
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GSK Investigational Site
Houston, Texas 77030
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Houston, TX
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GSK Investigational Site
Los Angeles, California 90025
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Los Angeles, CA
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GSK Investigational Site
Louisville, Kentucky 40202
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Louisville, KY
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GSK Investigational Site
Miami, Florida 33136
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Miami, FL
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GSK Investigational Site
Miami Beach, Florida 33140
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Miami Beach, FL
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GSK Investigational Site
Mount Vernon, New York 10550
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Mount Vernon, NY
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GSK Investigational Site
New Orleans, Louisiana 70112
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New Orleans, LA
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GSK Investigational Site
Newark, New Jersey 07112
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Newark, NJ
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GSK Investigational Site
Oakland, California 94611
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Oakland, CA
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GSK Investigational Site
Orlando, Florida 32806
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Orlando, FL
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GSK Investigational Site
Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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GSK Investigational Site
Portland, Oregon 97227
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Portland, OR
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GSK Investigational Site
Saint Louis, Missouri 63110
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Saint Louis, MO
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GSK Investigational Site
San Francisco, California 94115
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San Francisco, CA
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GSK Investigational Site
Valhalla, New York 10595
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Valhalla, NY
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GSK Investigational Site
Voorhees, New Jersey 08043
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Voorhees, NJ
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GSK Investigational Site
Washington, D.C., District of Columbia 20007
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Washington, D.C.,
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GSK Investigational Site
West Reading, Pennsylvania 19611
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West Reading, PA
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GSK Investigational Site
Wichita, Kansas 67207
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Wichita, KS
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