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

NCT ID: NCT00085943

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

866 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV Infection Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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LEXIVA (GW433908)

Intervention Type DRUG

Ritonavir

Intervention Type DRUG

KALETRA

Intervention Type DRUG

EPIVIR

Intervention Type DRUG

Ziagen

Intervention Type DRUG

Abacavir/Lamivudine

Intervention Type DRUG

Fosamprenavir

Intervention Type DRUG

Other Intervention Names

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LEXIVA (GW433908) Ritonavir Ziagen KALETRA Abacavir/Lamivudine EPIVIR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK Clinical Disclosure

Principal Investigators

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GSK Clinical Trials, Pharm.D.

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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

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

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

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Bradenton, Florida, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Jackson, Mississippi, United States

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Hillsborough, New Jersey, United States

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Newark, New Jersey, United States

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Somers Point, New Jersey, United States

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Voorhees Township, New Jersey, United States

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New York, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Toledo, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Charlottesville, Virginia, United States

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Hampton, Virginia, United States

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Lynchburg, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Vienna, , Austria

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Brussels, , Belgium

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Charleroi, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Le Kremlin-Bicêtre, , France

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Lyon, , France

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Lyon, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Saint-Denis, , France

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Fürth, Bavaria, Germany

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Munich, Bavaria, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Berlin, State of Berlin, Germany

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Ferrara, Emilia-Romagna, Italy

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Modena, Emilia-Romagna, Italy

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Rimini, Emilia-Romagna, Italy

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Busto Arsizio (VA), Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Turin, Piedmont, Italy

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Riga, , Latvia

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Luxembourg, , Luxembourg

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Bydgoszcz, , Poland

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Szczecin, , Poland

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Wroclaw, , Poland

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Cascais, , Portugal

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Bucharest, , Romania

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Iași, , Romania

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Barcelona, , Spain

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Elche (Alicante), , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Seville, , Spain

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Tarrasa, Barcelona, , Spain

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Valencia, , Spain

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Vigo ( Pontevedra), , Spain

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Lugano, , Switzerland

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Olten, , Switzerland

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Sankt Gallen, , Switzerland

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Countries

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United States Austria Belgium Canada France Germany Italy Latvia Luxembourg Poland Portugal Romania Spain Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 16890834 (View on PubMed)

Other Identifiers

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100732

Identifier Type: -

Identifier Source: org_study_id

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