NCT00528892

Switching From PI to RALtegravir in HIV Stable Patients

An Open-label, Randomized, 48-Week Study to Assess the Safety, Tolerability and Activity of Raltegravir When Replacing the Ritonavir-boosted PI Component of HAART in HIV-Infected Individuals With Viral Load Suppression on a Ritonavir-Boosted PI Containing Regimen.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesis is that switching from a ritonavir-boosted PI to raltegravir may be associated with an at least non-inferior effectiveness, virological response and safety, and even a better tolerability profile with regard to lipid metabolism, insulin resistance, body fat distribution as compared with continuation of the baseline regimen in HIV-1 seropositive males or females at least 18 years of age and older on ritonavir-boosted PI plus at least 2 other drugs and plasma viral RNA below 50 copies/mL.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir	switching PI to raltegravir
DRUG	boosted PI	continue on boosted-PI

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-09-12
• Last updated: 2010-03-31

Locations

1 site across 1 country: Spain