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

This study has been terminated.
Sponsor:
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00242879
First received: October 19, 2005
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus I
HIV-1 Infection
Drug: Physician determined comparator PI + ritonavir
Drug: GW640385 + ritonavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 130
Study Start Date: August 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Physician determined comparator PI + ritonavir Drug: GW640385 + ritonavir
    Other Names:
    • Physician determined comparator PI + ritonavir
    • GW640385 + ritonavir
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242879

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
GSK Investigational Site
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
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80204
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, Connecticut
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20009
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Bradenton, Florida, United States, 34205
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33306
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Miami Beach, Florida, United States, 33140
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60613
GSK Investigational Site
Chicago, Illinois, United States, 60657
GSK Investigational Site
Chicago, Illinois, United States, 60612-7230
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02118
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
GSK Investigational Site
Newark, New Jersey, United States, 7102
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14604
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29605
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Houston, Texas, United States, 77027
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
GSK Investigational Site
South Yarra, Victoria, Australia, 3141
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1L6
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Montreal, Quebec, Canada, H2X 2P4
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G2
France
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
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20099
Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Torino, Piemonte, Italy, 10149
GSK Investigational Site
Bari, Puglia, Italy, 70124
GSK Investigational Site
Bagno a Ripoli (FI), Toscana, Italy, 50126
Portugal
GSK Investigational Site
Cascais, Portugal, 2750
GSK Investigational Site
Lisboa, Portugal, 1150
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00731
GSK Investigational Site
San Juan, Puerto Rico, 00909-1711
Romania
GSK Investigational Site
Bucharest, Romania, 021105
GSK Investigational Site
Constanta, Romania, 900709
GSK Investigational Site
Iasi, Romania, 700116
United Kingdom
GSK Investigational Site
London, United Kingdom, EC1 7BE
GSK Investigational Site
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
ViiV Healthcare
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00242879     History of Changes
Other Study ID Numbers: HPR20001
Study First Received: October 19, 2005
Last Updated: April 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
treatment-experienced
RTV
protease inhibitor
ritonavir
GW640385
HIV-1

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Protease Inhibitors
Ritonavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014