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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
866

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2004

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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