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Protocol Summary for 100136

Protocol Summary
Protocol Id: 100136
Secondary Ids:
Title: See Detailed Description
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 65,238
IND/IDE Serial Number: 0055
Has Expanded Access?:
Study Type: interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
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.
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
Record Verification Date: December 2009
Status: Terminated
Why Study Stopped:
Study Start Date: December 2004
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Open Label
Masked Subject: None
Masked Caregiver: None
Masked Investigator: None
Masked Assessor: None
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • 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:
  • HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropism Viral resistance to GW873140 and other on-study drugs PK parameters of GW873140 in subjects receiving combination therapy.
Conditions:
  • Infection, Human Immunodeficiency Virus I
Keywords:
  • HIV infected
  • therapy-naive subjects
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A N/A
Enrollment: 175
Enrollment Type:
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information