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

HIV Infections Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038519
• Other study ID #: M00-261
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 31, 2002
• Last updated: July 27, 2006
• Start date: April 2001

Study information

• Verified date: July 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Amprenavir/ritonavir

• Saquinavir/ritonavir

Locations

Country	Name	City	State
Argentina	Fundacion Huesped	Buenos Aires
Argentina	Hospital Muniz - FUNDAI	Buenos Aires
Brazil	Hospital Evandro Chagas - Fiocryz	Rio de Janeiro
Brazil	Hospital do Servidor Publico Estadual de Sao Paulo	Sao Paulo	SP
Brazil	Hospital Heliopolis	Sao Paulo
Canada	Montreal Chest Institute/Royal Victoria Hospital	Montreal	Quebec
Canada	Ottawa Hospital General Campus	Ottawa	Ontario
Canada	Toronto General Hospital Division of The University Health Network	Toronto	Ontario
Canada	Phillip Sestak, M.D	Vancouver	British Columbia
France	Service du C.I.S.I.H. - C.H.U. de Grenoble	La Tronche
France	Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon	Paris
France	Hospital Tenon	Paris
France	Hospital Yves Le Foll	Saint Brieuc
France	La Seyne sur Mer, Hopital Chalucet	Toulon
France	Tour Drouet - C.H.U. Brabois	Vandoeuvre	Cedex
Italy	S. Raffaele Hospital	Milan
Italy	III Infectious Diseases Division IRCCS "L. Spallanzani"	Rome
Italy	IRCCS "L. Spallanzani"	Rome
Italy	Hospital "Amedeo di Savoia"	Torino
Poland	Wojewodzki Szpital Zakazny	Warszawa
Puerto Rico	Centro Familiar, Inc	Ponce
Puerto Rico	New Puerto Rico CONCRA	Rio Piedras
Spain	Hospital Germans Trias I Pujol	Badalona
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital De La Sta Creu I San Pau	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Hospital Carlos III	Madrid,
Spain	Hospital Universitario Vergen del Rocio	Sevilla
United Kingdom	Royal Free Hospital	London
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	AIDS Research Consortium of Atlanta, Inc.	Atlanta	Georgia
United States	David Wright, M.D.	Austin	Texas
United States	CORE Center	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	20th Avenue Medical Center Kaiser Permanente	Denver	Colorado
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Associates in Research	Fort Myers	Florida
United States	Gary J. Richmond, M.D.	Ft. Lauderdale	Florida
United States	Hampton Roads Medical Specialists	Hampton	Virginia
United States	Diversified Medical Practices, P.A.	Houston	Texas
United States	AIDS Health Care Foundation - Research Center	Los Angeles	California
United States	University of Miami School of Medicine	Miami	Florida
United States	Howard A. Grossman, M.D.	New York	New York
United States	John B. Montana, M.D.	New York,	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Phoenix Body Positive, Inc.	Phoenix,	Arizona
United States	The Research & Education Group	Portland	Oregon
United States	Bornemann Internal Medicine	Reading	Pennsylvania
United States	David Parks, M.D.	St. Louis	Missouri
United States	State University of New York at Stony Brook	Stony Brook,	New York
United States	Infectious Disease Research Institute, Inc.	Tampa	Florida
United States	Donna E. Sweet, M.D.	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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