Back to resultsObservational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
Primary Purpose
Infection, Human Immunodeficiency Virus I, HIV Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
No intervention; Observational study
Sponsored by
About this trial
This is an interventional trial for Infection, Human Immunodeficiency Virus I focused on measuring protease inhibitor, ritonavir, GW433908, HIV-1, fosamprenavir
Eligibility Criteria
Inclusion criteria: Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003. Must be failing virologically (>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908. Exclusion criteria: Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M. Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI). Have an acute CDC Class C event requiring therapeutic intervention. Are pregnant or lactating. Have any other condition which in the opinion of the investigator would preclude their participation.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00242840
Brief Title
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
Official Title
A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
4. Oversight
5. Study Description
Brief Summary
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus I, HIV Infection
Keywords
protease inhibitor, ritonavir, GW433908, HIV-1, fosamprenavir
7. Study Design
Study Phase
Phase 3
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
No intervention; Observational study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003.
Must be failing virologically (>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908.
Exclusion criteria:
Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M.
Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI).
Have an acute CDC Class C event requiring therapeutic intervention.
Are pregnant or lactating.
Have any other condition which in the opinion of the investigator would preclude their participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308/30309
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
GSK Investigational Site
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
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