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

NCT00242879 | Terminated Phase 2

• 1 other identifier: HPR20001
• Study Type: interventional
• Target: 130
• Locations: 11 countries
• Sites: 70

Brief Summary

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.

Conditions

Infection, Human Immunodeficiency Virus I; HIV-1 Infection

Keywords

treatment-experienced; RTV; protease inhibitor; ritonavir; GW640385; HIV-1

Outcome Measures

Primary Outcomes (3)

• Time averaged change in plasma HIV-1 RNA over 16 wks

• Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels

• Change in laboratory parameters

Secondary Outcomes (7)

• Assessments of HIV viral load changes

• GW640385 and RTV pharmacokinetic measurements

• The incidence of adverse events

• Changes in laboratory measurements

• ECG measurements

Interventions

Physician determined comparator PI + ritonavir DRUG

GW640385 + ritonavir DRUG

Also known as: Physician determined comparator PI + ritonavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (70)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Bakersfield, California, 93301, United States

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GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Los Angeles, California, 90046, United States

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GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

San Francisco, California, 94121, United States

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GSK Investigational Site

Denver, Colorado, 80204, United States

Location

GSK Investigational Site

Denver, Colorado, 80220, United States

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GSK Investigational Site

Norwalk, Connecticut, 06851, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20009, United States

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GSK Investigational Site

Bradenton, Florida, 34205, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33306, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

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GSK Investigational Site

Miami Beach, Florida, 33140, United States

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GSK Investigational Site

Chicago, Illinois, 60612-7230, United States

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GSK Investigational Site

Chicago, Illinois, 60613, United States

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GSK Investigational Site

Chicago, Illinois, 60657, United States

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GSK Investigational Site

Indianapolis, Indiana, 46202, United States

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GSK Investigational Site

Louisville, Kentucky, 40202, United States

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GSK Investigational Site

Baltimore, Maryland, 21201, United States

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GSK Investigational Site

Boston, Massachusetts, 02118, United States

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GSK Investigational Site

Boston, Massachusetts, 02215, United States

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GSK Investigational Site

Las Vegas, Nevada, 89102, United States

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GSK Investigational Site

Newark, New Jersey, 7102, United States

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GSK Investigational Site

Rochester, New York, 14604, United States

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GSK Investigational Site

Greenville, South Carolina, 29605, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

Houston, Texas, 77027, United States

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GSK Investigational Site

Hampton, Virginia, 23666, United States

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GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

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GSK Investigational Site

Liverpool, New South Wales, 2170, Australia

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GSK Investigational Site

South Yarra, Victoria, 3141, Australia

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GSK Investigational Site

Brussels, 1000, Belgium

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GSK Investigational Site

Vancouver, British Columbia, V6Z 2C7, Canada

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GSK Investigational Site

Toronto, Ontario, M4N 3M5, Canada

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GSK Investigational Site

Toronto, Ontario, M5B 1L6, Canada

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GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

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GSK Investigational Site

Montreal, Quebec, H2X 2P4, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G2, Canada

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GSK Investigational Site

Caen, 14000, France

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GSK Investigational Site

La Roche-sur-Yon, 85025, France

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GSK Investigational Site

Lyon, 69288, France

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GSK Investigational Site

Lyon, 69437, France

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GSK Investigational Site

Nantes, 44093, France

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GSK Investigational Site

Paris, 75475, France

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GSK Investigational Site

Paris, 75571, France

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GSK Investigational Site

Munich, Bavaria, 80335, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

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GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45122, Germany

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GSK Investigational Site

Berlin, 13353, Germany

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GSK Investigational Site

Hamburg, 20099, Germany

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GSK Investigational Site

Bari, Apulia, 70124, Italy

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GSK Investigational Site

Ferrara, Emilia-Romagna, 44100, Italy

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GSK Investigational Site

Rimini, Emilia-Romagna, 47900, Italy

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GSK Investigational Site

Milan, Lombardy, 20127, Italy

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GSK Investigational Site

Pavia, Lombardy, 27100, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10149, Italy

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GSK Investigational Site

Bagno A Ripoli (FI), Tuscany, 50126, Italy

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GSK Investigational Site

Cascais, 2750, Portugal

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GSK Investigational Site

Lisbon, 1150, Portugal

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GSK Investigational Site

Ponce, 00731, Puerto Rico

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GSK Investigational Site

San Juan, 00909-1711, Puerto Rico

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GSK Investigational Site

Bucharest, 021105, Romania

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GSK Investigational Site

Constanța, 900709, Romania

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GSK Investigational Site

Iași, 700116, Romania

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GSK Investigational Site

London, EC1 7BE, United Kingdom

Location

GSK Investigational Site

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Conditions

Infections

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 21, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

PT (2); AU (3); DE (6); IT (7); FR (7); CA (6); US (31); GB (2); PR (2); RO (3); BE (1)