KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

Last updated: May 12, 2011
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT00085943
100732
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HIV infected subjects that are naive to anti-HIV therapy.

  • History of a positive HIV test.

  • At least 1000 copies/mL of HIV in their blood as screening.

Exclusion

Exclusion Criteria:

  • Active HIV-related diseases.

  • Taking other investigational drugs.

  • Pregnant or breastfeeding females.

  • Not be suitable to participate per investigator opinion.

Study Design

Total Participants: 866
Study Start date:
May 01, 2004
Estimated Completion Date:

Study Description

A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks

Connect with a study center

  • GSK Investigational Site

    Vienna, A-1090
    Austria

    Site Not Available

  • GSK Investigational Site

    Bruxelles, 1000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Charleroi, 6000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liege, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Calgary, Alberta T2P 1H9
    Canada

    Site Not Available

  • GSK Investigational Site

    Ottawa, Ontario K1N 6N5
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M4T 3A7
    Canada

    Site Not Available

  • GSK Investigational Site

    Montreal, Quebec H2L 5B1
    Canada

    Site Not Available

  • GSK Investigational Site

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • GSK Investigational Site

    Le Kremlin Bicêtre Cedex, 94275
    France

    Site Not Available

  • GSK Investigational Site

    Le Kremlin Bicêtre Cedex, 94275
    France

    Site Not Available

  • GSK Investigational Site

    Lyon Cedex 02, 69288
    France

    Site Not Available

  • GSK Investigational Site

    Lyon Cedex 03, 69437
    France

    Site Not Available

  • GSK Investigational Site

    Paris, 75018
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 13, 75651
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 14, 75679
    France

    Site Not Available

  • GSK Investigational Site

    Saint Denis Cedex 01, 93205
    France

    Site Not Available

  • GSK Investigational Site

    Fuerth, Bayern 90762
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, Bayern 80331
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • GSK Investigational Site

    Hannover, Niedersachsen 30159
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 13353
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20099
    Germany

    Site Not Available

  • GSK Investigational Site

    Ferrara, Emilia-Romagna 44100
    Italy

    Site Not Available

  • GSK Investigational Site

    Modena, Emilia-Romagna 41100
    Italy

    Site Not Available

  • GSK Investigational Site

    Rimini, Emilia-Romagna 47900
    Italy

    Site Not Available

  • GSK Investigational Site

    Busto Arsizio (VA), Lombardia 21052
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano, Lombardia 20127
    Italy

    Site Not Available

  • GSK Investigational Site

    Torino, Piemonte 10149
    Italy

    Site Not Available

  • GSK Investigational Site

    Riga, LV 1006
    Latvia

    Site Not Available

  • GSK Investigational Site

    Luxembourg, 1210
    Luxembourg

    Site Not Available

  • GSK Investigational Site

    Bydgoszcz, 85-030
    Poland

    Site Not Available

  • GSK Investigational Site

    Szczecin, 71-455
    Poland

    Site Not Available

  • GSK Investigational Site

    Wroclaw, 51-149
    Poland

    Site Not Available

  • GSK Investigational Site

    Cascais, 2750
    Portugal

    Site Not Available

  • GSK Investigational Site

    Bucharest, 030303
    Romania

    Site Not Available

  • GSK Investigational Site

    Iasi, 700116
    Romania

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08003
    Spain

    Site Not Available

  • GSK Investigational Site

    Elche (Alicante), 03202
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Site Not Available

  • GSK Investigational Site

    Malaga, 29010
    Spain

    Site Not Available

  • GSK Investigational Site

    Palma de Mallorca, 07014
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • GSK Investigational Site

    Tarrasa, Barcelona, 08221
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46010
    Spain

    Site Not Available

  • GSK Investigational Site

    Vigo ( Pontevedra), 36204
    Spain

    Site Not Available

  • GSK Investigational Site

    Lugano, 6900
    Switzerland

    Site Not Available

  • GSK Investigational Site

    Olten, 4600
    Switzerland

    Site Not Available

  • GSK Investigational Site

    St Gallen, 9007
    Switzerland

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90046
    United States

    Site Not Available

  • GSK Investigational Site

    Sacramento, California 95825
    United States

    Site Not Available

  • GSK Investigational Site

    San Francisco, California 94115-1931
    United States

    Site Not Available

  • GSK Investigational Site

    Denver, Colorado 80220
    United States

    Site Not Available

  • GSK Investigational Site

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • GSK Investigational Site

    Bradenton, Florida 34205
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33136
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • GSK Investigational Site

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33614
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • GSK Investigational Site

    Chicago, Illinois 60613
    United States

    Site Not Available

  • GSK Investigational Site

    Indianapolis, Indiana 46280
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • GSK Investigational Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • GSK Investigational Site

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • GSK Investigational Site

    Hillsborough, New Jersey 08876
    United States

    Site Not Available

  • GSK Investigational Site

    Newark, New Jersey 07103
    United States

    Site Not Available

  • GSK Investigational Site

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • GSK Investigational Site

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • GSK Investigational Site

    Bronx, New York 10461
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10014
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, New York 14620
    United States

    Site Not Available

  • GSK Investigational Site

    Stony Brook, New York 11794-8091
    United States

    Site Not Available

  • GSK Investigational Site

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • GSK Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • GSK Investigational Site

    Toledo, Ohio 43614-5809
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • GSK Investigational Site

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29206-4713
    United States

    Site Not Available

  • GSK Investigational Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • GSK Investigational Site

    Hampton, Virginia 23666
    United States

    Site Not Available

  • GSK Investigational Site

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98101
    United States

    Site Not Available

  • GSK Investigational Site

    Spokane, Washington 99204
    United States

    Site Not Available

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