Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
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.
1 other identifier
interventional
16
10 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 31, 2002
CompletedFirst Posted
Study publicly available on registry
June 3, 2002
CompletedJuly 28, 2006
July 1, 2006
May 31, 2002
July 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (52)
Phoenix Body Positive, Inc.
Phoenix, Arizona, 85006, United States
AIDS Health Care Foundation - Research Center
Los Angeles, California, 90027, United States
20th Avenue Medical Center Kaiser Permanente
Denver, Colorado, 80205, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Gary J. Richmond, M.D.
Fort Lauderdale, Florida, 33316, United States
Associates in Research
Fort Myers, Florida, 33901, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, 30308, United States
CORE Center
Chicago, Illinois, 60612, United States
Donna E. Sweet, M.D.
Wichita, Kansas, 67214, United States
David Parks, M.D.
St Louis, Missouri, 63139, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Howard A. Grossman, M.D.
New York, New York, 10011, United States
John B. Montana, M.D.
New York, New York, 10011, United States
State University of New York at Stony Brook
Stony Brook, New York, 11794-08153, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0405, United States
The Research & Education Group
Portland, Oregon, 97209, United States
Bornemann Internal Medicine
Reading, Pennsylvania, 19601, United States
David Wright, M.D.
Austin, Texas, 78705, United States
Diversified Medical Practices, P.A.
Houston, Texas, 77027, United States
Hampton Roads Medical Specialists
Hampton, Virginia, 23666, United States
Hospital Muniz - FUNDAI
Buenos Aires, 4304-2180, Argentina
Fundacion Huesped
Buenos Aires, 4981-1855, Argentina
Hospital do Servidor Publico Estadual de Sao Paulo
São Paulo, São Paulo, 04029-000, Brazil
Hospital Evandro Chagas - Fiocryz
Rio de Janeiro, 21045-900, Brazil
Hospital Heliopolis
São Paulo, 01332-000, Brazil
Phillip Sestak, M.D
Vancouver, British Columbia, V6Z 3T1, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6, Canada
Toronto General Hospital Division of The University Health Network
Toronto, Ontario, M5G-2C4, Canada
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, H2X 2PA, Canada
Tour Drouet - C.H.U. Brabois
Vandœuvre-lès-Nancy, Cedex, 54511, France
Service du C.I.S.I.H. - C.H.U. de Grenoble
La Tronche, 38700, France
Hospital Tenon
Paris, 75020, France
Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
Paris, 75679, France
Hospital Yves Le Foll
Saint-Brieuc, 22023, France
La Seyne sur Mer, Hopital Chalucet
Toulon, 83056, France
S. Raffaele Hospital
Milan, 20127, Italy
III Infectious Diseases Division IRCCS "L. Spallanzani"
Rome, 00149, Italy
IRCCS "L. Spallanzani"
Rome, 00149, Italy
Hospital "Amedeo di Savoia"
Torino, 10149, Italy
Wojewodzki Szpital Zakazny
Warsaw, 01-201, Poland
Centro Familiar, Inc
Ponce, 00731, Puerto Rico
New Puerto Rico CONCRA
Rio Piedras, 00925, Puerto Rico
Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital De La Sta Creu I San Pau
Barcelona, 08025, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Hospital Carlos III
Madrid, 28010, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Universitario Vergen del Rocio
Seville, 41013, Spain
Royal Free Hospital
London, NW3 2QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eugene Sun, M.D.
Divisional Vice President, Infectious Diseases and Virology Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 31, 2002
First Posted
June 3, 2002
Study Start
April 1, 2001
Last Updated
July 28, 2006
Record last verified: 2006-07