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

  Show 70 Study Locations
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
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014