HIV Infections
Conditions
Keywords
treatment experienced, HIV
Brief 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48 | — |
Countries
Argentina, Brazil, Canada, France, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States