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TerminatedNCT00104429Updated May 30, 2017

GW873140 In Combination With Combivir In HIV Infected Subjects

A Phase 2 interventional study of GW873140 and Combivir in Infection, Human Immunodeficiency Virus I and HIV Infection, sponsored by ViiV Healthcare. Terminated at 51 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by ViiV Healthcare · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Infection, Human Immunodeficiency Virus I
  • HIV Infection

Keywords

  • HIV infections
  • therapy naive
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 125 is close to the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants

Interventions

  • DrugGW873140
  • DrugCombivir

    Also known as: GW873140

06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. - 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.

07

Study locations

51 sites
  • GSK Investigational Site
    Bakersfield, California 93301, United States
  • GSK Investigational Site
    Beverly Hills, California 90210, United States
  • GSK Investigational Site
    Los Angeles, California 90022, United States
  • GSK Investigational Site
    Los Angeles, California 90095, United States
  • GSK Investigational Site
    San Francisco, California 94114, United States
  • GSK Investigational Site
    Stanford, California 94305, United States
  • GSK Investigational Site
    Tarzana, California 30342, United States
  • GSK Investigational Site
    Denver, Colorado 80205, United States
  • GSK Investigational Site
    Washington, D.C., District of Columbia 20009, United States
  • GSK Investigational Site
    Miami, Florida 33136, United States
  • GSK Investigational Site
    Orlando, Florida 32804, United States
  • GSK Investigational Site
    Tampa, Florida 33607, United States
  • GSK Investigational Site
    Vero Beach, Florida 32960, United States
  • GSK Investigational Site
    Conyers, Georgia 30013, United States
  • GSK Investigational Site
    Chicago, Illinois 60612, United States
  • GSK Investigational Site
    Boston, Massachusetts 02114, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55404, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89102, United States
  • GSK Investigational Site
    Newark, New Jersey 7102, United States
  • GSK Investigational Site
    New York, New York 10008, United States
  • GSK Investigational Site
    Rochester, New York 14604, United States
  • GSK Investigational Site
    Portland, Oregon 97210, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • GSK Investigational Site
    Providence, Rhode Island 02908, United States
  • GSK Investigational Site
    Dallas, Texas 75208, United States
  • GSK Investigational Site
    Dallas, Texas 75215, United States
  • GSK Investigational Site
    Dallas, Texas 75246, United States
  • GSK Investigational Site
    Bruxelles, 1000, Belgium
  • GSK Investigational Site
    Ottawa, Ontario K1N 6N5, Canada
  • GSK Investigational Site
    Toronto, Ontario M4N 3M5, Canada
  • GSK Investigational Site
    Montreal, Quebec H2L 4P9, Canada
  • GSK Investigational Site
    Montreal, Quebec H2L 5B1, Canada
  • GSK Investigational Site
    Levallois-Perret, 92300, France
  • GSK Investigational Site
    Lyon Cedex 02, 69288, France
  • GSK Investigational Site
    Nantes, 44093, France
  • GSK Investigational Site
    Paris, 75018, France
  • GSK Investigational Site
    Wuerzburg, Bayern 97080, Germany
  • GSK Investigational Site
    Frankfurt, Hessen 60590, Germany
  • GSK Investigational Site
    Hannover, Niedersachsen 30625, Germany
  • GSK Investigational Site
    Brescia, Lombardia 25125, Italy
  • GSK Investigational Site
    Milano, Lombardia 20127, Italy
  • GSK Investigational Site
    Milano, Lombardia 20157, Italy
  • GSK Investigational Site
    Coimbra, 3000-075, Portugal
  • GSK Investigational Site
    Lisboa, 1169-100, Portugal
  • GSK Investigational Site
    Porto, 4200-319, Portugal
  • GSK Investigational Site
    Madrid, 28029, Spain
  • GSK Investigational Site
    Manchester, Lancashire M8 5RB, United Kingdom
  • GSK Investigational Site
    Brighton, Sussex East BN2 1ES, United Kingdom
  • GSK Investigational Site
    Birmingham, Warwickshire B29 6JD, United Kingdom
  • GSK Investigational Site
    London, EC1 7BE, United Kingdom
  • GSK Investigational Site
    London, SW10 9TH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00104429
Lead sponsor
ViiV Healthcare
Responsible party
Sponsor
First posted
Mar 1, 2005
Start date
Jan 2005
Primary completion
Jan 2006
Completion
Jan 2006
Last update
May 30, 2017

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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