GW873140 In Combination With Kaletra In HIV Infected Subjects

NCT00102778 | Terminated Phase 2

• 1 other identifier: 100136
• Study Type: interventional
• Target: 175
• Locations: 10 countries
• Sites: 70

Brief Summary

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

Conditions

Infection, Human Immunodeficiency Virus I; HIV Infection

Keywords

HIV infected; therapy-naive subjects

Outcome Measures

Primary Outcomes (1)

• To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.

Secondary Outcomes (1)

• HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.

Interventions

GW873140 DRUG

Kaletra (lopinavir/ritonavir) DRUG

Also known as: GW873140

Eligibility Criteria

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

You may qualify if:

• HIV infected, therapy-naive 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 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
• Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
• Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an 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.

You may not qualify if:

• No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.
• No active Class C AIDS-defining illness.
• No laboratory abnormalities at screen.
• No significant blood loss prior to study start.
• No pregnant or breastfeeding women.
• Additional qualifying criteria to be determined by the physician.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (70)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Tucson, Arizona, 85745, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

Long Beach, California, 90813, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

San Francisco, California, 94115-1931, United States

Location

GSK Investigational Site

Denver, Colorado, 80220, United States

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20036, United States

Location

GSK Investigational Site

Bradenton, Florida, 34205, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33306, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33901, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33408, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30339, United States

Location

GSK Investigational Site

Chicago, Illinois, 60613, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70127-0800, United States

Location

GSK Investigational Site

Jackson, Mississippi, 39202, United States

Location

GSK Investigational Site

Santa Fe, New Mexico, 87505, United States

Location

GSK Investigational Site

New York, New York, 10014, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Portland, Oregon, 97209, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18103, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19102, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 2C7, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Copenhagen, DK-2100, Denmark

Location

GSK Investigational Site

Hvidovre, DK-2650, Denmark

Location

GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

GSK Investigational Site

Marseille, 13005, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Paris, 75571, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Paris, 75970, France

Location

GSK Investigational Site

Saint-Denis, 93205, France

Location

GSK Investigational Site

Tourcoing, 59208, France

Location

GSK Investigational Site

Villejuif, 94804, France

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

GSK Investigational Site

Berlin, 13353, Germany

Location

GSK Investigational Site

Hamburg, 20099, Germany

Location

GSK Investigational Site

Hamburg, 20146, Germany

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10149, Italy

Location

GSK Investigational Site

Amsterdam, 1066 EC, Netherlands

Location

GSK Investigational Site

Cascais, 2750, Portugal

Location

GSK Investigational Site

Lisbon, 1150, Portugal

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Manchester, Lancashire, M8 5RB, United Kingdom

Location

GSK Investigational Site

Brighton, Sussex East, BN2 1ES, United Kingdom

Location

GSK Investigational Site

Birmingham, Warwickshire, B29 6JD, United Kingdom

Location

GSK Investigational Site

London, EC1 7BE, United Kingdom

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Infections; HIV Infections

Interventions

aplaviroc; lopinavir-ritonavir drug combination; Lopinavir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

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: February 1, 2005
• First Posted: February 2, 2005
• Study Start: December 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

NL (1); CA (5); US (32); PT (2); GB (5); DK (2); DE (6); ES (2); FR (12); IT (3)