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

NCT00085943 | Completed Phase 3

• 1 other identifier: 100732
• Study Type: interventional
• Target: 866
• Locations: 14 countries
• Sites: 119

Brief 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.

Conditions

HIV Infection; Infection, Human Immunodeficiency Virus

Keywords

ritonavir; abacavir; HIV; lopinavir; lamivudine; fosamprenavir; Epzicom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

LEXIVA (GW433908) DRUG

Ritonavir DRUG

KALETRA DRUG

EPIVIR DRUG

Ziagen DRUG

Abacavir/Lamivudine DRUG

Fosamprenavir DRUG

Also known as: LEXIVA (GW433908), Ritonavir, Ziagen, KALETRA, Abacavir/Lamivudine, EPIVIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active HIV-related diseases.
• Taking other investigational drugs.
• Pregnant or breastfeeding females.
• Not be suitable to participate per investigator opinion.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (119)

GSK Investigational Site

Birmingham, Alabama, 35233, United States

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GSK Investigational Site

Phoenix, Arizona, 85006, United States

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Los Angeles, California, 90046, United States

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GSK Investigational Site

Sacramento, California, 95825, United States

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GSK Investigational Site

San Francisco, California, 94115-1931, United States

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GSK Investigational Site

Denver, Colorado, 80220, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20036, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

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GSK Investigational Site

Bradenton, Florida, 34205, United States

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Fort Lauderdale, Florida, 33308, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32804, United States

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GSK Investigational Site

Pembroke Pines, Florida, 33024, United States

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GSK Investigational Site

Tampa, Florida, 33602, United States

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GSK Investigational Site

Tampa, Florida, 33607, United States

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GSK Investigational Site

Tampa, Florida, 33614, United States

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GSK Investigational Site

Atlanta, Georgia, 30308, United States

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GSK Investigational Site

Atlanta, Georgia, 30339, United States

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GSK Investigational Site

Chicago, Illinois, 60612-7230, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

Chicago, Illinois, 60613, United States

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GSK Investigational Site

Chicago, Illinois, 60657, United States

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Indianapolis, Indiana, 46202, United States

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GSK Investigational Site

Indianapolis, Indiana, 46280, United States

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GSK Investigational Site

Lexington, Kentucky, 40536, United States

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GSK Investigational Site

Baltimore, Maryland, 21201, United States

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GSK Investigational Site

Boston, Massachusetts, 02115, United States

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GSK Investigational Site

Boston, Massachusetts, 02118, United States

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GSK Investigational Site

Jackson, Mississippi, 39202, United States

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GSK Investigational Site

Hillsborough, New Jersey, 08876, United States

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GSK Investigational Site

Newark, New Jersey, 07103, United States

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GSK Investigational Site

Somers Point, New Jersey, 08244, United States

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GSK Investigational Site

Voorhees Township, New Jersey, 08043, United States

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New York, New York, 10014, United States

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GSK Investigational Site

Rochester, New York, 14620, United States

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GSK Investigational Site

Stony Brook, New York, 11794-8091, United States

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GSK Investigational Site

The Bronx, New York, 10461, United States

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GSK Investigational Site

The Bronx, New York, 10468, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27516, United States

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GSK Investigational Site

Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27710, United States

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Greenville, North Carolina, 27858, United States

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Toledo, Ohio, 43614-5809, United States

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Philadelphia, Pennsylvania, 19102, United States

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Philadelphia, Pennsylvania, 19107, United States

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Providence, Rhode Island, 02906, United States

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Columbia, South Carolina, 29206-4713, United States

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Knoxville, Tennessee, 37920, United States

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GSK Investigational Site

Dallas, Texas, 75208, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

Fort Worth, Texas, 76104, United States

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GSK Investigational Site

Houston, Texas, 77004, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Charlottesville, Virginia, 22908, United States

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GSK Investigational Site

Hampton, Virginia, 23666, United States

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GSK Investigational Site

Lynchburg, Virginia, 24501, United States

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GSK Investigational Site

Seattle, Washington, 98101, United States

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GSK Investigational Site

Seattle, Washington, 98104, United States

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GSK Investigational Site

Spokane, Washington, 99204, United States

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GSK Investigational Site

Vienna, A-1090, Austria

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Brussels, 1000, Belgium

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Charleroi, 6000, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Calgary, Alberta, T2P 1H9, Canada

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Ottawa, Ontario, K1N 6N5, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M4T 3A7, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Montreal, Quebec, H2L 4P9, Canada

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GSK Investigational Site

Montreal, Quebec, H2L 5B1, Canada

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GSK Investigational Site

Bordeaux, 33076, France

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GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

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GSK Investigational Site

Lyon, 69288, France

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GSK Investigational Site

Lyon, 69437, France

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GSK Investigational Site

Paris, 75018, France

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GSK Investigational Site

Paris, 75475, France

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GSK Investigational Site

Paris, 75651, France

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GSK Investigational Site

Paris, 75679, France

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GSK Investigational Site

Saint-Denis, 93205, France

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GSK Investigational Site

Fürth, Bavaria, 90762, Germany

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GSK Investigational Site

Munich, Bavaria, 80331, Germany

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GSK Investigational Site

Hamburg, Hamburg, 20099, Germany

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GSK Investigational Site

Hamburg, Hamburg, 20146, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

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Hanover, Lower Saxony, 30159, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13353, Germany

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GSK Investigational Site

Ferrara, Emilia-Romagna, 44100, Italy

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Modena, Emilia-Romagna, 41100, Italy

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GSK Investigational Site

Rimini, Emilia-Romagna, 47900, Italy

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GSK Investigational Site

Busto Arsizio (VA), Lombardy, 21052, Italy

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GSK Investigational Site

Milan, Lombardy, 20127, Italy

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GSK Investigational Site

Milan, Lombardy, 20157, Italy

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GSK Investigational Site

Turin, Piedmont, 10149, Italy

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Riga, LV 1006, Latvia

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Luxembourg, 1210, Luxembourg

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Bydgoszcz, 85-030, Poland

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Szczecin, 71-455, Poland

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Wroclaw, 51-149, Poland

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GSK Investigational Site

Cascais, 2750, Portugal

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Bucharest, 030303, Romania

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GSK Investigational Site

Iași, 700116, Romania

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Elche (Alicante), 03202, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28047, Spain

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GSK Investigational Site

Málaga, 29010, Spain

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GSK Investigational Site

Palma de Mallorca, 07014, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Tarrasa, Barcelona, 08221, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Vigo ( Pontevedra), 36204, Spain

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GSK Investigational Site

Lugano, 6900, Switzerland

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GSK Investigational Site

Olten, 4600, Switzerland

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GSK Investigational Site

Sankt Gallen, 9007, Switzerland

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Related Publications (1)

• Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1.

  PMID: 16890834 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Infections; Acquired Immunodeficiency Syndrome

Interventions

fosamprenavir; Ritonavir; lopinavir-ritonavir drug combination; Lamivudine; abacavir; abacavir, lamivudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• GSK Clinical Trials, Pharm.D.

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2004
• First Posted: June 21, 2004
• Study Start: May 1, 2004
• Last Updated: May 16, 2011

Record last verified: 2011-05

Locations

AU (1); BE (5); IT (7); ES (11); PT (1); US (60); LA (1); CA (8); PL (3); CH (3); FR (9); LU (1); RO (2); DE (7)