GW873140 In Combination With Combivir In HIV Infected Subjects

May 25, 2017 updated by: ViiV Healthcare

A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

Study Overview

Status

Status

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

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 IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults

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.
125

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 2

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

  • Belgium
      • Bruxelles, Belgium, 1000
        • GSK Investigational Site
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2L 5B1
        • GSK Investigational Site
  • France
      • Levallois-Perret, France, 92300
        • GSK Investigational Site
      • Lyon Cedex 02, France, 69288
        • GSK Investigational Site
      • Nantes, France, 44093
        • GSK Investigational Site
      • Paris, France, 75018
        • GSK Investigational Site
  • Germany
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25125
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20127
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • GSK Investigational Site
      • Lisboa, Portugal, 1169-100
        • GSK Investigational Site
      • Porto, Portugal, 4200-319
        • GSK Investigational Site
  • Spain
      • Madrid, Spain, 28029
        • GSK Investigational Site
  • United Kingdom
      • London, United Kingdom, EC1 7BE
        • GSK Investigational Site
      • London, United Kingdom, SW10 9TH
        • GSK Investigational Site
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M8 5RB
        • GSK Investigational Site
    • Sussex East
      • Brighton, Sussex East, United Kingdom, BN2 1ES
        • GSK Investigational Site
    • Warwickshire
      • Birmingham, Warwickshire, United Kingdom, B29 6JD
        • GSK Investigational Site
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site
      • Los Angeles, California, United States, 90022
        • GSK Investigational Site
      • San Francisco, California, United States, 94114
        • GSK Investigational Site
      • Stanford, California, United States, 94305
        • GSK Investigational Site
      • Tarzana, California, United States, 30342
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80205
        • GSK Investigational Site
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20009
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Tampa, Florida, United States, 33607
        • GSK Investigational Site
      • Vero Beach, Florida, United States, 32960
        • GSK Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30013
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • GSK Investigational Site
    • New Jersey
      • Newark, New Jersey, United States, 7102
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10008
        • GSK Investigational Site
      • Rochester, New York, United States, 14604
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75208
        • GSK Investigational Site
      • Dallas, Texas, United States, 75215
        • 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

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • HIV infected subjects.
  • Females must be of either non-childbearing age, or have a negative pregnancy test.
  • All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
  • Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
  • Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.
  • Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
  • Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
  • Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
  • Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
  • Signed and dated written informed consent prior to study entry.

Exclusion criteria:

  • Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening.
  • Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
  • Active Class C AIDS-defining illness.
  • Laboratory abnormalities at screen.
  • Significant blood loss prior to study start.
  • Pregnant or breastfeeding women.
  • Additional qualifying criteria to be determined by the physician.

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 Assignment
  • Masking: None (Open Label)

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 viral loads <400 copies/mL remaining on randomized treatment through Week 12

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
- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.

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.
ViiV Healthcare

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.
January 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2006

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).
February 28, 2005

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.
February 28, 2005

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.
March 1, 2005

Study Record Updates

Last Update Posted (Actual)

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 30, 2017

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 25, 2017

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, 2017

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.
  • 102881

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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