Text Size

Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

This study has been completed.
Sponsor:
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00242840
First received: October 19, 2005
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus I
HIV Infection
 Drug: No intervention; Observational study
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

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

Further study details as provided by ViiV Healthcare:

Enrollment: 20
Study Start Date: June 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: No intervention; Observational study
    Other Name: No intervention; Observational study
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242840

Locations
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308/30309
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Augusta, Georgia, United States, 30912
Italy
GSK Investigational Site
Brescia, Lombardia, Italy, 25125
Sponsors and Collaborators
ViiV Healthcare
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: NCT00242840     History of Changes
Other Study ID Numbers: APV30007
Study First Received: October 19, 2005
Last Updated: April 1, 2013
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
protease inhibitor
ritonavir
GW433908
HIV-1
fosamprenavir

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
Protease Inhibitors
 Fosamprenavir
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013