A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

May 25, 2017 updated by: ViiV Healthcare

Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

Study Overview

Detailed Description

A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • 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

    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • GSK Investigational Site
      • Liverpool, New South Wales, Australia, 2170
        • GSK Investigational Site
    • Victoria
      • South Yarra, Victoria, Australia, 3141
        • GSK Investigational Site
      • Bruxelles, Belgium, 1000
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5B 1L6
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2X 2P4
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • GSK Investigational Site
      • Caen, France, 14000
        • GSK Investigational Site
      • La Roche Sur Yon cedex 9, France, 85025
        • GSK Investigational Site
      • Lyon Cedex 02, France, 69288
        • GSK Investigational Site
      • Lyon Cedex 03, France, 69437
        • GSK Investigational Site
      • Nantes, France, 44093
        • GSK Investigational Site
      • Paris Cedex 10, France, 75475
        • GSK Investigational Site
      • Paris Cedex 12, France, 75571
        • GSK Investigational Site
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Hamburg, Germany, 20099
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Germany, 80335
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • GSK Investigational Site
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44100
        • GSK Investigational Site
      • Rimini, Emilia-Romagna, Italy, 47900
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20127
        • GSK Investigational Site
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Italy, 10149
        • GSK Investigational Site
    • Puglia
      • Bari, Puglia, Italy, 70124
        • GSK Investigational Site
    • Toscana
      • Bagno a Ripoli (FI), Toscana, Italy, 50126
        • GSK Investigational Site
      • Cascais, Portugal, 2750
        • GSK Investigational Site
      • Lisboa, Portugal, 1150
        • GSK Investigational Site
      • Ponce, Puerto Rico, 00731
        • GSK Investigational Site
      • San Juan, Puerto Rico, 00909-1711
        • GSK Investigational Site
      • Bucharest, Romania, 021105
        • GSK Investigational Site
      • Constanta, Romania, 900709
        • GSK Investigational Site
      • Iasi, Romania, 700116
        • GSK Investigational Site
      • London, United Kingdom, EC1 7BE
        • GSK Investigational Site
      • London, United Kingdom, SW10 9TH
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
    • California
      • Bakersfield, California, United States, 93301
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Los Angeles, California, United States, 90046
        • GSK Investigational Site
      • San Francisco, California, United States, 94115
        • GSK Investigational Site
      • San Francisco, California, United States, 94121
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80204
        • GSK Investigational Site
      • Denver, Colorado, United States, 80220
        • GSK Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • GSK Investigational Site
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • GSK Investigational Site
      • Washington, D.C., District of Columbia, United States, 20009
        • GSK Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34205
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33306
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Miami Beach, Florida, United States, 33140
        • GSK Investigational Site
    • Illinois
      • 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
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02118
        • 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
      • Rochester, New York, United States, 14604
        • GSK Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Houston, Texas, United States, 77027
        • GSK Investigational Site
    • Virginia
      • Hampton, Virginia, United States, 23666
        • 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

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
  • HIV-1 infected subjects.
  • Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
  • Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
  • Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
  • Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
  • Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
  • Be willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

  • Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
  • Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
  • Active CDC Class C disease at screening.
  • Pregnant or breastfeeding women.
  • Protocol-specified laboratory abnormalities at Screening.

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

Outcome Measure
Time averaged change in plasma HIV-1 RNA over 16 wks
Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels
Change in laboratory parameters

Secondary Outcome Measures

Outcome Measure
Assessments of HIV viral load changes
GW640385 and RTV pharmacokinetic measurements
The incidence of adverse events
Changes in laboratory measurements
ECG measurements
HIV viral resistance assessment
Immunologic measures

Collaborators and Investigators

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

Sponsor

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

August 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

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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