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Status:

TERMINATED

GW873140 In Combination With Combivir In HIV Infected Subjects

Lead Sponsor:

ViiV Healthcare

Conditions:

Infection, Human Immunodeficiency Virus I

HIV Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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.

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 co...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    January 1 2006

    Estimated Enrollment :

    125 Patients enrolled

    Trial Details

    Trial ID

    NCT00104429

    Start Date

    January 1 2005

    End Date

    January 1 2006

    Last Update

    May 30 2017

    Active Locations (51)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 13 (51 locations)

    1

    GSK Investigational Site

    Bakersfield, California, United States, 93301

    2

    GSK Investigational Site

    Beverly Hills, California, United States, 90210

    3

    GSK Investigational Site

    Los Angeles, California, United States, 90022

    4

    GSK Investigational Site

    Los Angeles, California, United States, 90095