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Completed

NCT Number: NCT00242840

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

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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Key information

Conditions

Infection, Human Immunodeficiency Virus I Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Brescia, Lombardy, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention; Observational study

Drug

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Oct 21, 2005
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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