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

Tracking Information

First Received Date ^ICMJE

May 31, 2002

Last Updated Date

July 27, 2006

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038519 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Amprenavir/ritonavir
Drug: Saquinavir/ritonavir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Canada, France, Italy, Poland, Puerto Rico, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00038519

Responsible Party

Study ID Numbers ^ICMJE

M00-261

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Eugene Sun, M.D.

Divisional Vice President, Infectious Diseases and Virology Development

Information Provided By

Abbott

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP