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Observational Study Of A Prot...

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

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus I HIV Infection

Interventions

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No intervention; Observational study

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers