GW873140 In Combination With Combivir In HIV Infected Subjects

NCT ID: NCT00104429

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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

Conditions

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Infection, Human Immunodeficiency Virus I HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GW873140

Intervention Type DRUG

Combivir

Intervention Type DRUG

Other Intervention Names

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GW873140

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bakersfield, California, United States

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GSK Investigational Site

Beverly Hills, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Tarzana, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Conyers, Georgia, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Las Vegas, Nevada, United States

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Newark, New Jersey, United States

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New York, New York, United States

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Rochester, New York, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Brussels, , Belgium

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Levallois-Perret, , France

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Lyon, , France

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Nantes, , France

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Paris, , France

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Würzburg, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Brescia, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Madrid, , Spain

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Manchester, Lancashire, United Kingdom

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Brighton, Sussex East, United Kingdom

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Birmingham, Warwickshire, United Kingdom

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GSK Investigational Site

London, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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Countries

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United States Belgium Canada France Germany Italy Portugal Spain United Kingdom

Other Identifiers

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102881

Identifier Type: -

Identifier Source: org_study_id

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