GW873140 In Combination With Combivir In HIV Infected Subjects

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00104429
First received: February 28, 2005
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus I Infection
HIV Infection
Drug: GW873140
Drug: Combivir
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 GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12

Secondary Outcome Measures:
  • - 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.

Estimated Enrollment: 125
Study Start Date: January 2005
Intervention Details:
    Drug: GW873140 Drug: Combivir
    Other Names:
    • GW873140
    • 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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104429

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
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
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80205
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20009
United States, Florida
GSK Investigational Site
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
United States, Georgia
GSK Investigational Site
Conyers, Georgia, United States, 30013
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02114
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
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
New York, New York, United States, 10008
GSK Investigational Site
Rochester, New York, United States, 14604
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02908
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75215
GSK Investigational Site
Dallas, Texas, United States, 75208
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1N 6N5
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
France
GSK Investigational Site
Levallois-Perret, France, 92300
GSK Investigational Site
Lyon Cedex 02, France, 69288
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Paris, France, 75018
Germany
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97080
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Italy
GSK Investigational Site
Brescia, Lombardia, Italy, 25125
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Milano, Lombardia, Italy, 20157
Portugal
GSK Investigational Site
Coimbra, Portugal, 3000-075
GSK Investigational Site
Lisboa, Portugal, 1169-100
GSK Investigational Site
Porto, Portugal, 4200-319
Spain
GSK Investigational Site
Madrid, Spain, 28029
United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
GSK Investigational Site
Brighton, Sussex East, United Kingdom, BN2 1ES
GSK Investigational Site
Birmingham, Warwickshire, United Kingdom, B29 6JD
GSK Investigational Site
London, United Kingdom, SW10 9TH
GSK Investigational Site
London, United Kingdom, EC1 7BE
Sponsors and Collaborators
GlaxoSmithKline
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: NCT00104429     History of Changes
Other Study ID Numbers: 102881
Study First Received: February 28, 2005
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV infections
therapy naive

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
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 21, 2014