Clinical trial NCT00038532: Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
Official title: An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: treatment experienced
HIV
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-06-03
Enrollment: 24
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 amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.


Eligibility criteria: Inclusion:

* Remain on present anti-HIV drugs during screening until a new regimen is started.
* Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
* Have an HIV which shows reduced susceptibility to lopinavir.
* Are at least 18 years old.
* Are not presently ill.
* Have not been treated for an opportunistic infection within 30 days of screening.
* Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
* Agree to use an accepted barrier method of birth control.

Exclusion:

* Female subject is pregnant or lactating.
* Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
* Are taking chemotherapy.
* Have a medical problem with their pancreas.
* Have been screened for this study within the past 12 weeks.
* Appear to be unsuitable in the opinion of the doctor.

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: Fountain Valley
country: United States
facility: Paul J. Cimoch, M.D.
state: California
city: Los Angeles
country: United States
facility: AIDS Health Care Foundation - Research Center
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Diseases Medical Associates
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: Galveston
country: United States
facility: University of Texas Medical Branch
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 Heliopolis
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: Grenoble
country: France
facility: Hopital Michalon - C.H.U. de Grenoble
city: Paris
country: France
facility: Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon
city: Paris
country: France
facility: Hopital Tenon
city: Saint Brieuc
country: France
facility: Hospital Yves Le Foll
city: Toulon
country: France
facility: La Seyne sur Mer, Hopital Chalucet
city: Vandoeuvre
country: France
facility: C.H.U. Brabois - Tour Drouet, Rue du Morvan
city: Berlin
country: Germany
facility: CORE Center
city: Dusseldorf
country: Germany
facility: Universitatsklinikum
city: Frankfurt
country: Germany
facility: Klinikum J.W. Goethe Universitat
city: Hamburg
country: Germany
facility: Institut fur Immunologie Pathologie und Molekularbiologie
city: Stuttgart
country: Germany
facility: Albrecht Ulmer, M.D.
city: Milan
country: Italy
facility: S. Raffaele Hospital
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: