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GW873140 In Combination With Kaletra In HIV Infected Subjects

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102778
First received: February 1, 2005
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus I Infection
HIV Infection
Drug: GW873140
Drug: Kaletra (lopinavir/ritonavir)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 175
Study Start Date: December 2004
Intervention Details:
    Drug: GW873140 Drug: Kaletra (lopinavir/ritonavir)
    Other Names:
    • GW873140
    • Kaletra (lopinavir/ritonavir)
Detailed Description:

A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102778

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
GSK Investigational Site
Tucson, Arizona, United States, 85745
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Long Beach, California, United States, 90813
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Los Angeles, California, United States, 90027
GSK Investigational Site
San Francisco, California, United States, 94115-1931
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
GSK Investigational Site
Washington, District of Columbia, United States, 20036
United States, Florida
GSK Investigational Site
Bradenton, Florida, United States, 34205
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33306
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
West Palm Beach, Florida, United States, 33408
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
GSK Investigational Site
Chicago, Illinois, United States, 60613
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70127-0800
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, New Mexico
GSK Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, New York
GSK Investigational Site
New York, New York, United States, 10014
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97209
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18103
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77027
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G2
Denmark
GSK Investigational Site
Hvidovre, Denmark, DK-2650
GSK Investigational Site
Koebenhavn, Denmark, DK-2100
France
GSK Investigational Site
Le Kremlin Bicêtre Cedex, France, 94275
GSK Investigational Site
Marseille, France, 13005
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris Cedex 12, France, 75571
GSK Investigational Site
Paris Cedex 13, France, 75651
GSK Investigational Site
Paris Cedex 14, France, 75679
GSK Investigational Site
Paris Cedex 20, France, 75970
GSK Investigational Site
Saint Denis Cedex 01, France, 93205
GSK Investigational Site
Tourcoing, France, 59208
GSK Investigational Site
Villejuif Cedex, France, 94804
Germany
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20146
GSK Investigational Site
Hamburg, Germany, 20099
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Torino, Piemonte, Italy, 10149
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1066 EC
Portugal
GSK Investigational Site
Cascais, Portugal, 2750
GSK Investigational Site
Lisboa, Portugal, 1150
Spain
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Sevilla, Spain, 41013
United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
GSK Investigational Site
Brighton, Sussex East, United Kingdom, BN2 1ES
GSK Investigational Site
Birmingham, Warwickshire, United Kingdom, B29 6JD
GSK Investigational Site
London, United Kingdom, EC1 7BE
GSK Investigational Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00102778     History of Changes
Other Study ID Numbers: 100136
Study First Received: February 1, 2005
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV infected
therapy-naive subjects

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014