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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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
Columbia, South Carolina 29203
2102
mi
from 91732
Columbia, SC
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Akron, Ohio 44313
2037
mi
from 91732
Akron, OH
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Allentown, Pennsylvania 18102
2356
mi
from 91732
Allentown, PA
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Atlanta, Georgia 30341
1922
mi
from 91732
Atlanta, GA
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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Bakersfield, California 93309
106
mi
from 91732
Bakersfield, CA
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Charlotte, North Carolina 28203
2100
mi
from 91732
Charlotte, NC
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Chicago, Illinois 60611
1730
mi
from 91732
Chicago, IL
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Dallas, Texas 75230
1223
mi
from 91732
Dallas, TX
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Decatur, Georgia 30033
1924
mi
from 91732
Decatur, GA
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East Orange, New Jersey
2422
mi
from 91732
East Orange, NJ
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Fort Collins, Colorado 80528
840
mi
from 91732
Fort Collins, CO
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Fort Lauderdale, Florida 33308
2315
mi
from 91732
Fort Lauderdale, FL
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Fort Myers, Florida 33916
2205
mi
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Fort Myers, FL
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Greenville, North Carolina 27858
2290
mi
from 91732
Greenville, NC
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Greenville, South Carolina 29615
2022
mi
from 91732
Greenville, SC
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Guadalajara, Jalisco 44340
?
mi
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Guadalajara,
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Hampton, Virginia 23666
2329
mi
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Hampton, VA
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Harlingen, Texas 78550
1327
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Harlingen, TX
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Hillsborough, New Jersey 08844
2400
mi
from 91732
Hillsborough, NJ
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Houston, Texas 77030
1357
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from 91732
Houston, TX
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Los Angeles, California 90025
24
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Los Angeles, CA
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Louisville, Kentucky 40202
1813
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Louisville, KY
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Miami, Florida 33136
2321
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Miami, FL
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Miami Beach, Florida 33140
2324
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Miami Beach, FL
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Mount Vernon, New York 10550
2179
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Mount Vernon, NY
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New Orleans, Louisiana 70112
1655
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New Orleans, LA
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Newark, New Jersey 07112
2422
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Newark, NJ
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Oakland, California 94611
349
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Oakland, CA
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Orlando, Florida 32806
2186
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Orlando, FL
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Philadelphia, Pennsylvania 19104
2373
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Philadelphia, PA
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Portland, Oregon 97227
829
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Portland, OR
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Saint Louis, Missouri 63110
1570
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Saint Louis, MO
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San Francisco, California 94115
356
mi
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San Francisco, CA
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Valhalla, New York 10595
2443
mi
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Valhalla, NY
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Voorhees, New Jersey 08043
2386
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Voorhees, NJ
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Washington, D.C., District of Columbia 20007
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Washington, D.C.,
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West Reading, Pennsylvania 19611
2332
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West Reading, PA
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Wichita, Kansas 67207
1186
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Wichita, KS
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