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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)

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ViiV Healthcare

Status and phase

Completed
Phase 3

Conditions

HIV Infection
Infection, Human Immunodeficiency Virus I

Treatments

Drug: No intervention; Observational study

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242840
APV30007

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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