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

Abbott

Status and phase

Completed

Phase 3

Phase 2

Conditions

HIV Infections

Treatments

Drug: Amprenavir/ritonavir

Drug: Saquinavir/ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00038519

M00-261

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.