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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amprenavir/ritonavir
Saquinavir/ritonavir
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring treatment experienced, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Body Positive, Inc.
  • AIDS Health Care Foundation - Research Center
  • 20th Avenue Medical Center Kaiser Permanente
  • University of Colorado Health Sciences Center
  • IDC Research Initiative
  • Associates in Research
  • Gary J. Richmond, M.D.
  • University of Miami School of Medicine
  • Infectious Disease Research Institute, Inc.
  • AIDS Research Consortium of Atlanta, Inc.
  • CORE Center
  • Donna E. Sweet, M.D.
  • David Parks, M.D.
  • Saint Michael's Medical Center
  • John B. Montana, M.D.
  • Howard A. Grossman, M.D.
  • State University of New York at Stony Brook
  • University of Cincinnati Medical Center
  • The Research & Education Group
  • Bornemann Internal Medicine
  • David Wright, M.D.
  • Diversified Medical Practices, P.A.
  • Hampton Roads Medical Specialists
  • Hospital Muniz - FUNDAI
  • Fundacion Huesped
  • Hospital do Servidor Publico Estadual de Sao Paulo
  • Hospital Evandro Chagas - Fiocryz
  • Hospital Heliopolis
  • Phillip Sestak, M.D
  • Ottawa Hospital General Campus
  • Toronto General Hospital Division of The University Health Network
  • Montreal Chest Institute/Royal Victoria Hospital
  • Tour Drouet - C.H.U. Brabois
  • Service du C.I.S.I.H. - C.H.U. de Grenoble
  • Hospital Tenon
  • Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
  • Hospital Yves Le Foll
  • La Seyne sur Mer, Hopital Chalucet
  • S. Raffaele Hospital
  • III Infectious Diseases Division IRCCS "L. Spallanzani"
  • IRCCS "L. Spallanzani"
  • Hospital "Amedeo di Savoia"
  • Wojewodzki Szpital Zakazny
  • Centro Familiar, Inc
  • New Puerto Rico CONCRA
  • Hospital Germans Trias I Pujol
  • Hospital De La Sta Creu I San Pau
  • Hospital Clinic I Provincial
  • Hospital Carlos III
  • Hospital La Paz
  • Hospital Universitario Vergen del Rocio
  • Royal Free Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 31, 2002
Last Updated
July 27, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00038519
Brief Title
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
treatment experienced, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amprenavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
Saquinavir/ritonavir
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Sun, M.D.
Organizational Affiliation
Divisional Vice President, Infectious Diseases and Virology Development
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix Body Positive, Inc.
City
Phoenix,
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
AIDS Health Care Foundation - Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
20th Avenue Medical Center Kaiser Permanente
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Associates in Research
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Gary J. Richmond, M.D.
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Infectious Disease Research Institute, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research Consortium of Atlanta, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Donna E. Sweet, M.D.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
David Parks, M.D.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
John B. Montana, M.D.
City
New York,
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Howard A. Grossman, M.D.
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
State University of New York at Stony Brook
City
Stony Brook,
State/Province
New York
ZIP/Postal Code
11794-08153
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0405
Country
United States
Facility Name
The Research & Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Bornemann Internal Medicine
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19601
Country
United States
Facility Name
David Wright, M.D.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Diversified Medical Practices, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Hampton Roads Medical Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Hospital Muniz - FUNDAI
City
Buenos Aires
ZIP/Postal Code
4304-2180
Country
Argentina
Facility Name
Fundacion Huesped
City
Buenos Aires
ZIP/Postal Code
4981-1855
Country
Argentina
Facility Name
Hospital do Servidor Publico Estadual de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04029-000
Country
Brazil
Facility Name
Hospital Evandro Chagas - Fiocryz
City
Rio de Janeiro
ZIP/Postal Code
21045-900
Country
Brazil
Facility Name
Hospital Heliopolis
City
Sao Paulo
ZIP/Postal Code
01332-000
Country
Brazil
Facility Name
Phillip Sestak, M.D
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 3T1
Country
Canada
Facility Name
Ottawa Hospital General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital Division of The University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G-2C4
Country
Canada
Facility Name
Montreal Chest Institute/Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2PA
Country
Canada
Facility Name
Tour Drouet - C.H.U. Brabois
City
Vandoeuvre
State/Province
Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Service du C.I.S.I.H. - C.H.U. de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hospital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Hospital Yves Le Foll
City
Saint Brieuc
ZIP/Postal Code
22023
Country
France
Facility Name
La Seyne sur Mer, Hopital Chalucet
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
S. Raffaele Hospital
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
III Infectious Diseases Division IRCCS "L. Spallanzani"
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
IRCCS "L. Spallanzani"
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Hospital "Amedeo di Savoia"
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Wojewodzki Szpital Zakazny
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Centro Familiar, Inc
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
New Puerto Rico CONCRA
City
Rio Piedras
ZIP/Postal Code
00925
Country
Puerto Rico
Facility Name
Hospital Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital De La Sta Creu I San Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Carlos III
City
Madrid,
ZIP/Postal Code
28010
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Vergen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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