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
Akron, Ohio 44313
111
mi
from 43215
Akron, OH
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GSK Investigational Site
Allentown, Pennsylvania 18102
400
mi
from 43215
Allentown, PA
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GSK Investigational Site
Atlanta, Georgia 30341
424
mi
from 43215
Atlanta, GA
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GSK Investigational Site
Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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GSK Investigational Site
Bakersfield, California 93309
1982
mi
from 43215
Bakersfield, CA
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GSK Investigational Site
Charlotte, North Carolina 28203
348
mi
from 43215
Charlotte, NC
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GSK Investigational Site
Chicago, Illinois 60611
274
mi
from 43215
Chicago, IL
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GSK Investigational Site
Columbia, South Carolina 29203
418
mi
from 43215
Columbia, SC
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GSK Investigational Site
Dallas, Texas 75230
905
mi
from 43215
Dallas, TX
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GSK Investigational Site
Decatur, Georgia 30033
430
mi
from 43215
Decatur, GA
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GSK Investigational Site
East Orange, New Jersey
467
mi
from 43215
East Orange, NJ
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GSK Investigational Site
Fort Collins, Colorado 80528
1156
mi
from 43215
Fort Collins, CO
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GSK Investigational Site
Fort Lauderdale, Florida 33308
966
mi
from 43215
Fort Lauderdale, FL
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GSK Investigational Site
Fort Myers, Florida 33916
924
mi
from 43215
Fort Myers, FL
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GSK Investigational Site
Greenville, North Carolina 27858
430
mi
from 43215
Greenville, NC
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GSK Investigational Site
Greenville, South Carolina 29615
353
mi
from 43215
Greenville, SC
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GSK Investigational Site
Guadalajara, Jalisco 44340
?
mi
from 43215
Guadalajara,
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GSK Investigational Site
Hampton, Virginia 23666
410
mi
from 43215
Hampton, VA
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GSK Investigational Site
Harlingen, Texas 78550
1272
mi
from 43215
Harlingen, TX
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GSK Investigational Site
Hillsborough, New Jersey 08844
443
mi
from 43215
Hillsborough, NJ
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GSK Investigational Site
Houston, Texas 77030
995
mi
from 43215
Houston, TX
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GSK Investigational Site
Los Angeles, California 90025
1983
mi
from 43215
Los Angeles, CA
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GSK Investigational Site
Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
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GSK Investigational Site
Miami, Florida 33136
992
mi
from 43215
Miami, FL
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GSK Investigational Site
Miami Beach, Florida 33140
991
mi
from 43215
Miami Beach, FL
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GSK Investigational Site
Mount Vernon, New York 10550
288
mi
from 43215
Mount Vernon, NY
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GSK Investigational Site
New Orleans, Louisiana 70112
797
mi
from 43215
New Orleans, LA
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GSK Investigational Site
Newark, New Jersey 07112
466
mi
from 43215
Newark, NJ
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GSK Investigational Site
Oakland, California 94611
2094
mi
from 43215
Oakland, CA
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GSK Investigational Site
Orlando, Florida 32806
797
mi
from 43215
Orlando, FL
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GSK Investigational Site
Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
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GSK Investigational Site
Portland, Oregon 97227
2026
mi
from 43215
Portland, OR
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GSK Investigational Site
Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
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GSK Investigational Site
San Francisco, California 94115
2108
mi
from 43215
San Francisco, CA
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GSK Investigational Site
Valhalla, New York 10595
491
mi
from 43215
Valhalla, NY
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GSK Investigational Site
Voorhees, New Jersey 08043
427
mi
from 43215
Voorhees, NJ
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GSK Investigational Site
Washington, D.C., District of Columbia 20007
?
mi
from 43215
Washington, D.C.,
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GSK Investigational Site
West Reading, Pennsylvania 19611
374
mi
from 43215
West Reading, PA
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GSK Investigational Site
Wichita, Kansas 67207
780
mi
from 43215
Wichita, KS
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