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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00085943
First received: June 17, 2004
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
HIV Infection
Infection, Human Immunodeficiency Virus
Drug: LEXIVA (GW433908)
Drug: Ritonavir
Drug: KALETRA
Drug: EPIVIR
Drug: Ziagen
Drug: Abacavir/Lamivudine
Drug: Fosamprenavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

Secondary Outcome Measures:
  • Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events.

Estimated Enrollment: 866
Study Start Date: May 2004
Intervention Details:
    Drug: LEXIVA (GW433908) Drug: Ritonavir Drug: KALETRA Drug: EPIVIR Drug: Ziagen Drug: Abacavir/Lamivudine Drug: Fosamprenavir
    Other Names:
    • LEXIVA (GW433908)
    • Ritonavir
    • Ziagen
    • KALETRA
    • Abacavir/Lamivudine
    • Fosamprenavir
    • EPIVIR
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 Criteria:

  • Active HIV-related diseases.
  • Taking other investigational drugs.
  • Pregnant or breastfeeding females.
  • Not be suitable to participate per investigator opinion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085943

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90046
GSK Investigational Site
Sacramento, California, United States, 95825
GSK Investigational Site
San Francisco, California, United States, 94115-1931
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20036
GSK Investigational Site
Washington, District of Columbia, United States, 20037
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Bradenton, Florida, United States, 34205
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
GSK Investigational Site
Tampa, Florida, United States, 33602
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30339
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
GSK Investigational Site
Chicago, Illinois, United States, 60612-7230
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60613
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46280
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
GSK Investigational Site
Boston, Massachusetts, United States, 02118
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08876
GSK Investigational Site
Newark, New Jersey, United States, 07103
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10468
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
New York, New York, United States, 10014
GSK Investigational Site
Rochester, New York, United States, 14620
GSK Investigational Site
Stony Brook, New York, United States, 11794-8091
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27516
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Greenville, North Carolina, United States, 27858
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29206-4713
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77004
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
GSK Investigational Site
Hampton, Virginia, United States, 23666
GSK Investigational Site
Lynchburg, Virginia, United States, 24501
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104
GSK Investigational Site
Seattle, Washington, United States, 98101
GSK Investigational Site
Spokane, Washington, United States, 99204
Austria
GSK Investigational Site
Vienna, Austria, A-1090
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Charleroi, Belgium, 6000
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liege, Belgium, 4000
GSK Investigational Site
Liège, Belgium, 4000
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2P 1H9
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1N 6N5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2C4
GSK Investigational Site
Toronto, Ontario, Canada, M4T 3A7
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
France
GSK Investigational Site
Bordeaux Cedex, France, 33076
GSK Investigational Site
Le Kremlin Bicêtre Cedex, France, 94275
GSK Investigational Site
Lyon Cedex 02, France, 69288
GSK Investigational Site
Lyon Cedex 03, France, 69437
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris Cedex 13, France, 75651
GSK Investigational Site
Paris Cedex 14, France, 75679
GSK Investigational Site
Saint Denis Cedex 01, France, 93205
Germany
GSK Investigational Site
Fuerth, Bayern, Germany, 90762
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20099
GSK Investigational Site
Hamburg, Germany, 20146
Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Busto Arsizio (VA), Lombardia, Italy, 21052
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Torino, Piemonte, Italy, 10149
Latvia
GSK Investigational Site
Riga, Latvia, LV 1006
Luxembourg
GSK Investigational Site
Luxembourg, Luxembourg, 1210
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-030
GSK Investigational Site
Szczecin, Poland, 71-455
GSK Investigational Site
Wroclaw, Poland, 51-149
Portugal
GSK Investigational Site
Cascais, Portugal, 2750
Romania
GSK Investigational Site
Bucharest, Romania, 030303
GSK Investigational Site
Iasi, Romania, 700116
Spain
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Vigo ( Pontevedra), Spain, 36204
Switzerland
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Olten, Switzerland, 4600
GSK Investigational Site
St Gallen, Switzerland, 9007
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, Pharm.D. GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00085943     History of Changes
Other Study ID Numbers: 100732
Study First Received: June 17, 2004
Last Updated: May 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ritonavir
abacavir
HIV
lopinavir
lamivudine
fosamprenavir
Epzicom

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Abacavir
Fosamprenavir
Lamivudine
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014