Overview
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AbbottTreatments:
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.