Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Amprenavir; HIV Protease Inhibitors; Protease Inhibitors; Ritonavir; Saquinavir

Criteria

Inclusion:

• Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.

• Subject demonstrates reduced susceptibility to lopinavir.

• Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.

• The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.

• Subject is at least 18 years of age.

• Subject has not been treated for an active opportunistic infection within 30 days of screening.

Exclusion:

• Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.

• Female subject pregnant or lactating.

• Use of an Investigational drug within 30 days prior to the initiation of drug dosing.

• Subject is receiving systemic chemotherapy.

• Subject has a history of acute or chronic pancreatitis.