Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
Completed · Phase 3
Conditions studied: Infection, Human Immunodeficiency Virus I, HIV Infection
In brief
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.
Key facts
- Study ID
- NCT00242840
- Run by
- ViiV Healthcare
- People needed
- 20
- Starts
- 2003-06-01
- Expected to finish
- 2006-01-01
- Last updated by the study team
- 2017-05-30
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Fort Lauderdale, Florida, United States
- GSK Investigational Site — Orlando, Florida, United States
- GSK Investigational Site — Tampa, Florida, United States
- GSK Investigational Site — Atlanta, Georgia, United States
- GSK Investigational Site — Atlanta, Georgia, United States
- GSK Investigational Site — Augusta, Georgia, United States
- GSK Investigational Site — Brescia, Lombardy, Italy
Full record on ClinicalTrials.gov
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