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GW873140 In Combination With Kaletra In HIV Infected Subjects

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ClinicalTrials.gov Identifier: NCT00102778
Recruitment Status : Terminated
First Posted : February 2, 2005
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects
Study Start Date : December 2004
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: GW873140 Drug: Kaletra (lopinavir/ritonavir)
    Other Name: GW873140

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102778


  Show 70 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00102778     History of Changes
Other Study ID Numbers: 100136
First Posted: February 2, 2005    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by ViiV Healthcare:
HIV infected
therapy-naive subjects

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors