GW873140 In Combination With Combivir In HIV Infected Subjects

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: Terminated
• Conditions: HIV Infection; Infection, Human Immunodeficiency Virus I
• Intervention / Treatment: Drug: GW873140; Drug: Combivir

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: Interventional
• Enrollment: 125
• Phase: Phase 2

Contacts and Locations

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

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 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

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
Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12

Secondary Outcome Measures

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

• Sponsor: ViiV Healthcare

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: February 28, 2005
• First Submitted That Met QC Criteria: February 28, 2005
• First Posted (Estimate): March 1, 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 infections; therapy naive
• 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; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Lamivudine, zidovudine drug combination; Aplaviroc
• Other Study ID Numbers: 102881