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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

October 19, 2005
April 1, 2013
June 2003
January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00242840 on ClinicalTrials.gov Archive Site
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Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
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.

Not Provided
Interventional
Phase 3
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  • Infection, Human Immunodeficiency Virus I
  • HIV Infection
Drug: No intervention; Observational study
Other Name: No intervention; Observational study
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2006
January 2006   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT00242840
APV30007
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ViiV Healthcare
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
ViiV Healthcare
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP