NCT00094523

Fosamprenavir Versus Other Protease Inhibitors

A Phase IIIB/IV, Open-label, Multi-center Trial to Evaluate the Safety, Tolerability, and Efficiency of HIV-1 Infected Subjects Switching Their Current Protease-inhibitor Therapies for a Fosamprenavir Therapy Over 48 Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to evaluate and compare safety, tolerability of subjects who successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir. This is a 48-week study, where subjects who were assigned to be in their original PI-group have the option of switching to fosamprenavir on week 24. Prior to being assigned their treatment group, subjects had to be suppressed for at least three months. All subjects also take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.

Conditions

• Infection, Human Immunodeficiency Virus I

Interventions

Type	Name	Description
DRUG	Fosamprenavir	Fosamprenavir

Timeline

• Start date: 2004-12-14
• Primary completion: 2007-06-29
• Completion: 2007-06-29
• First posted: 2004-10-21
• Last updated: 2018-04-18

Locations

52 sites across 2 countries: United States, Puerto Rico