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

May 12, 2011 updated by: GlaxoSmithKline

See Detailed Description

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

866

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • GSK Investigational Site
  • Belgium
      • 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
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2P 1H9
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5B 1W8
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4T 3A7
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2L 5B1
        • GSK Investigational Site
  • France
      • 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
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Hamburg, Germany, 20099
        • GSK Investigational Site
      • Hamburg, Germany, 20146
        • GSK Investigational Site
    • Bayern
      • Fuerth, Bayern, Germany, 90762
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80331
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44100
        • GSK Investigational Site
      • Modena, Emilia-Romagna, Italy, 41100
        • GSK Investigational Site
      • Rimini, Emilia-Romagna, Italy, 47900
        • GSK Investigational Site
    • Lombardia
      • Busto Arsizio (VA), Lombardia, Italy, 21052
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20127
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Italy, 10149
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1006
        • GSK Investigational Site
  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • GSK Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-030
        • GSK Investigational Site
      • Szczecin, Poland, 71-455
        • GSK Investigational Site
      • Wroclaw, Poland, 51-149
        • GSK Investigational Site
  • Portugal
      • Cascais, Portugal, 2750
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 030303
        • GSK Investigational Site
      • Iasi, Romania, 700116
        • GSK Investigational Site
  • Spain
      • 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
        • GSK Investigational Site
  • Switzerland
      • Lugano, Switzerland, 6900
        • GSK Investigational Site
      • Olten, Switzerland, 4600
        • GSK Investigational Site
      • St Gallen, Switzerland, 9007
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
    • California
      • Los Angeles, California, United States, 90046
        • GSK Investigational Site
      • Sacramento, California, United States, 95825
        • GSK Investigational Site
      • San Francisco, California, United States, 94115-1931
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20037
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20036
        • GSK Investigational Site
    • Florida
      • 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, 33614
        • GSK Investigational Site
      • Tampa, Florida, United States, 33607
        • GSK Investigational Site
      • Tampa, Florida, United States, 33602
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30339
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60612-7230
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60613
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60657
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46280
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • New Jersey
      • 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
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site
      • Bronx, New York, United States, 10468
        • 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
        • GSK Investigational Site
    • North Carolina
      • 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
        • GSK Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43614-5809
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19102
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29206-4713
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75208
        • 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
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
      • Hampton, Virginia, United States, 23666
        • GSK Investigational Site
      • Lynchburg, Virginia, United States, 24501
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98101
        • GSK Investigational Site
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, Pharm.D., GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

June 17, 2004

First Submitted That Met QC Criteria

June 18, 2004

First Posted (ESTIMATE)

June 21, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100732

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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