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

Use our guide to learn which trials are right for you!

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
Saint Louis, Missouri 63110
415
mi
from
Saint Louis, MO
Click here to add this to my saved trials
GSK Investigational Site
Akron, Ohio 44313
896
mi
from
Akron, OH
Click here to add this to my saved trials
GSK Investigational Site
Allentown, Pennsylvania 18102
1209
mi
from
Allentown, PA
Click here to add this to my saved trials
GSK Investigational Site
Atlanta, Georgia 30341
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
GSK Investigational Site
Austin, Texas 78705
515
mi
from
Austin, TX
Click here to add this to my saved trials
GSK Investigational Site
Bakersfield, California 93309
1187
mi
from
Bakersfield, CA
Click here to add this to my saved trials
GSK Investigational Site
Charlotte, North Carolina 28203
957
mi
from
Charlotte, NC
Click here to add this to my saved trials
GSK Investigational Site
Chicago, Illinois 60611
611
mi
from
Chicago, IL
Click here to add this to my saved trials
GSK Investigational Site
Columbia, South Carolina 29203
969
mi
from
Columbia, SC
Click here to add this to my saved trials
GSK Investigational Site
Dallas, Texas 75230
340
mi
from
Dallas, TX
Click here to add this to my saved trials
GSK Investigational Site
Decatur, Georgia 30033
805
mi
from
Decatur, GA
Click here to add this to my saved trials
GSK Investigational Site
East Orange, New Jersey
1276
mi
from
East Orange, NJ
Click here to add this to my saved trials
GSK Investigational Site
Fort Collins, Colorado 80528
428
mi
from
Fort Collins, CO
Click here to add this to my saved trials
GSK Investigational Site
Fort Lauderdale, Florida 33308
1306
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
GSK Investigational Site
Fort Myers, Florida 33916
1207
mi
from
Fort Myers, FL
Click here to add this to my saved trials
GSK Investigational Site
Greenville, North Carolina 27858
1140
mi
from
Greenville, NC
Click here to add this to my saved trials
GSK Investigational Site
Greenville, South Carolina 29615
883
mi
from
Greenville, SC
Click here to add this to my saved trials
GSK Investigational Site
Guadalajara, Jalisco 44340
?
mi
from
Guadalajara,
Click here to add this to my saved trials
GSK Investigational Site
Hampton, Virginia 23666
1174
mi
from
Hampton, VA
Click here to add this to my saved trials
GSK Investigational Site
Harlingen, Texas 78550
798
mi
from
Harlingen, TX
Click here to add this to my saved trials
GSK Investigational Site
Hillsborough, New Jersey 08844
1252
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
GSK Investigational Site
Houston, Texas 77030
572
mi
from
Houston, TX
Click here to add this to my saved trials
GSK Investigational Site
Los Angeles, California 90025
1179
mi
from
Los Angeles, CA
Click here to add this to my saved trials
GSK Investigational Site
Louisville, Kentucky 40202
657
mi
from
Louisville, KY
Click here to add this to my saved trials
GSK Investigational Site
Miami, Florida 33136
1320
mi
from
Miami, FL
Click here to add this to my saved trials
GSK Investigational Site
Miami Beach, Florida 33140
1321
mi
from
Miami Beach, FL
Click here to add this to my saved trials
GSK Investigational Site
Mount Vernon, New York 10550
1053
mi
from
Mount Vernon, NY
Click here to add this to my saved trials
GSK Investigational Site
New Orleans, Louisiana 70112
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
GSK Investigational Site
Newark, New Jersey 07112
1276
mi
from
Newark, NJ
Click here to add this to my saved trials
GSK Investigational Site
Oakland, California 94611
1327
mi
from
Oakland, CA
Click here to add this to my saved trials
GSK Investigational Site
Orlando, Florida 32806
1144
mi
from
Orlando, FL
Click here to add this to my saved trials
GSK Investigational Site
Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
Click here to add this to my saved trials
GSK Investigational Site
Portland, Oregon 97227
1384
mi
from
Portland, OR
Click here to add this to my saved trials
GSK Investigational Site
San Francisco, California 94115
1340
mi
from
San Francisco, CA
Click here to add this to my saved trials
GSK Investigational Site
Valhalla, New York 10595
1299
mi
from
Valhalla, NY
Click here to add this to my saved trials
GSK Investigational Site
Voorhees, New Jersey 08043
1236
mi
from
Voorhees, NJ
Click here to add this to my saved trials
GSK Investigational Site
Washington, D.C., District of Columbia 20007
?
mi
from
Washington, D.C.,
Click here to add this to my saved trials
GSK Investigational Site
West Reading, Pennsylvania 19611
1184
mi
from
West Reading, PA
Click here to add this to my saved trials
GSK Investigational Site
Wichita, Kansas 67207
32
mi
from
Wichita, KS
Click here to add this to my saved trials