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

HIV Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242840
• Other study ID #: APV30007
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2005
• Last updated: May 25, 2017
• Start date: June 2003
• Est. completion date: January 2006

Study information

• Verified date: May 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus I

Intervention

Drug:
• No intervention; Observational study

Locations

Country	Name	City	State
Italy	GSK Investigational Site	Brescia	Lombardia
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	Fort Lauderdale	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

United States,  Italy,