Clinical trial NCT00038519: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Keywords: treatment experienced
HIV
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-06-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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