- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242840
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
May 25, 2017 updated by: ViiV Healthcare
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lombardia
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Brescia, Lombardia, Italy, 25125
- GSK Investigational Site
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Florida
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Fort Lauderdale, Florida, United States, 33308
- GSK Investigational Site
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Orlando, Florida, United States, 32804
- GSK Investigational Site
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Tampa, Florida, United States, 33614
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30308
- GSK Investigational Site
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Atlanta, Georgia, United States, 30308/30309
- GSK Investigational Site
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Augusta, Georgia, United States, 30912
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 19, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- APV30007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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