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A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

NCT ID: NCT00242879

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-06-30

Brief Summary

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This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

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Detailed Description

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A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (\>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

Conditions

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Infection, Human Immunodeficiency Virus I HIV-1 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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Physician determined comparator PI + ritonavir

Intervention Type DRUG

GW640385 + ritonavir

Intervention Type DRUG

Other Intervention Names

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Physician determined comparator PI + ritonavir

Eligibility Criteria

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Inclusion Criteria

* 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
* HIV-1 infected subjects.
* Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
* Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
* Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
* Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
* Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
* Be willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion Criteria

* Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
* Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
* Active CDC Class C disease at screening.
* Pregnant or breastfeeding women.
* Protocol-specified laboratory abnormalities at Screening.
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

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Bakersfield, California, United States

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GSK Investigational Site

Fountain Valley, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

San Francisco, California, United States

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GSK Investigational Site

San Francisco, California, United States

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GSK Investigational Site

Denver, Colorado, United States

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GSK Investigational Site

Denver, Colorado, United States

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GSK Investigational Site

Norwalk, Connecticut, United States

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GSK Investigational Site

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

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GSK Investigational Site

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

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GSK Investigational Site

Bradenton, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Miami Beach, Florida, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Indianapolis, Indiana, United States

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GSK Investigational Site

Louisville, Kentucky, United States

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GSK Investigational Site

Baltimore, Maryland, United States

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GSK Investigational Site

Boston, Massachusetts, United States

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GSK Investigational Site

Boston, Massachusetts, United States

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GSK Investigational Site

Las Vegas, Nevada, United States

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GSK Investigational Site

Newark, New Jersey, United States

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GSK Investigational Site

Rochester, New York, United States

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GSK Investigational Site

Greenville, South Carolina, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Hampton, Virginia, United States

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GSK Investigational Site

Darlinghurst, New South Wales, Australia

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GSK Investigational Site

Liverpool, New South Wales, Australia

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GSK Investigational Site

South Yarra, Victoria, Australia

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GSK Investigational Site

Brussels, , Belgium

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GSK Investigational Site

Vancouver, British Columbia, Canada

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GSK Investigational Site

Toronto, Ontario, Canada

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GSK Investigational Site

Toronto, Ontario, Canada

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GSK Investigational Site

Montreal, Quebec, Canada

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GSK Investigational Site

Montreal, Quebec, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, Canada

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GSK Investigational Site

Caen, , France

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GSK Investigational Site

La Roche-sur-Yon, , France

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GSK Investigational Site

Lyon, , France

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GSK Investigational Site

Lyon, , France

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GSK Investigational Site

Nantes, , France

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GSK Investigational Site

Paris, , France

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GSK Investigational Site

Paris, , France

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, Germany

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GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Hamburg, , Germany

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GSK Investigational Site

Bari, Apulia, Italy

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GSK Investigational Site

Ferrara, Emilia-Romagna, Italy

Site Status

GSK Investigational Site

Rimini, Emilia-Romagna, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Pavia, Lombardy, Italy

Site Status

GSK Investigational Site

Turin, Piedmont, Italy

Site Status

GSK Investigational Site

Bagno A Ripoli (FI), Tuscany, Italy

Site Status

GSK Investigational Site

Cascais, , Portugal

Site Status

GSK Investigational Site

Lisbon, , Portugal

Site Status

GSK Investigational Site

Ponce, , Puerto Rico

Site Status

GSK Investigational Site

San Juan, , Puerto Rico

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Constanța, , Romania

Site Status

GSK Investigational Site

Iași, , Romania

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Italy Portugal Puerto Rico Romania United Kingdom

Other Identifiers

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HPR20001

Identifier Type: -

Identifier Source: org_study_id

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