GW873140 In Combination With Kaletra In HIV Infected Subjects

A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects

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

Study Overview

• Status: Terminated
• Conditions: HIV Infection; Infection, Human Immunodeficiency Virus I
• Intervention / Treatment: Drug: Kaletra (lopinavir/ritonavir); Drug: GW873140

Detailed Description

A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects

• Study Type: Interventional
• Enrollment: 175
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • GSK Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 2N2
      • GSK Investigational Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 4G2
      • GSK Investigational Site
• Denmark
  • Hvidovre, Denmark, DK-2650
    • GSK Investigational Site
  • Koebenhavn, Denmark, DK-2100
    • GSK Investigational Site
• France
  • Le Kremlin Bicêtre Cedex, France, 94275
    • GSK Investigational Site
  • Marseille, France, 13005
    • GSK Investigational Site
  • Nantes, France, 44093
    • GSK Investigational Site
  • Paris, France, 75018
    • GSK Investigational Site
  • Paris Cedex 10, France, 75475
    • GSK Investigational Site
  • Paris Cedex 12, France, 75571
    • GSK Investigational Site
  • Paris Cedex 13, France, 75651
    • GSK Investigational Site
  • Paris Cedex 14, France, 75679
    • GSK Investigational Site
  • Paris Cedex 20, France, 75970
    • GSK Investigational Site
  • Saint Denis Cedex 01, France, 93205
    • GSK Investigational Site
  • Tourcoing, France, 59208
    • GSK Investigational Site
  • Villejuif Cedex, France, 94804
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13353
    • GSK Investigational Site
  • Hamburg, Germany, 20099
    • GSK Investigational Site
  • Hamburg, Germany, 20146
    • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50937
      • GSK Investigational Site
• Italy
  • Lombardia
    • Milano, Lombardia, Italy, 20127
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20157
      • GSK Investigational Site
  • Piemonte
    • Torino, Piemonte, Italy, 10149
      • GSK Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1066 EC
    • GSK Investigational Site
• Portugal
  • Cascais, Portugal, 2750
    • GSK Investigational Site
  • Lisboa, Portugal, 1150
    • GSK Investigational Site
• Spain
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Sevilla, Spain, 41013
    • GSK Investigational Site
• United Kingdom
  • London, United Kingdom, EC1 7BE
    • GSK Investigational Site
  • London, United Kingdom, NW3 2QG
    • 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
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85745
      • GSK Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • GSK Investigational Site
    • Long Beach, California, United States, 90813
      • GSK Investigational Site
    • Los Angeles, California, United States, 90069
      • GSK Investigational Site
    • Los Angeles, California, United States, 90027
      • 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, D.C., District of Columbia, United States, 20007
      • GSK Investigational Site
    • Washington, D.C., District of Columbia, United States, 20036
      • GSK Investigational Site
  • Florida
    • Bradenton, Florida, United States, 34205
      • GSK Investigational Site
    • Fort Lauderdale, Florida, United States, 33306
      • GSK Investigational Site
    • Fort Lauderdale, Florida, United States, 33308
      • GSK Investigational Site
    • Fort Myers, Florida, United States, 33901
      • GSK Investigational Site
    • Orlando, Florida, United States, 32804
      • GSK Investigational Site
    • Tampa, Florida, United States, 33614
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33408
      • 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, 60613
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60657
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • GSK Investigational Site
    • New Orleans, Louisiana, United States, 70127-0800
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10014
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97209
      • GSK Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19102
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77027
      • GSK Investigational Site
  • Virginia
    • Hampton, Virginia, United States, 23666
      • GSK Investigational Site

Participation Criteria

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:

• HIV infected, therapy-naive 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 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
• Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
• Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an 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:

• No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.
• No active Class C AIDS-defining illness.
• No laboratory abnormalities at screen.
• No significant blood loss prior to study start.
• No pregnant or breastfeeding women.
• Additional qualifying criteria to be determined by the physician.

Study Plan

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
To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.

Secondary Outcome Measures

Outcome Measure
HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.

Collaborators and Investigators

• Sponsor: ViiV Healthcare

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: February 1, 2005
• First Submitted That Met QC Criteria: February 1, 2005
• First Posted (Estimate): February 2, 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

Terms related to this study

• Keywords: HIV infected; therapy-naive subjects
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Ritonavir; Lopinavir; Aplaviroc
• Other Study ID Numbers: 100136