Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

Condition(s) targeted: HIV Infections

Intervention: Amprenavir/ritonavir (Drug); Saquinavir/ritonavir (Drug); Efavirenz (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Eugene Sun, M.D., Study Chair, Affiliation: Divisional Vice President, Infectious Diseases and Virology Development

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Fundacion Huesped, Buenos Aires 4981-1855, Argentina

Hospital Muniz - FUNDAI, Buenos Aires 4304-2180, Argentina

Hospital Heliopolis, Sao Paulo 01332-000, Brazil

Hospital Yves Le Foll, Saint Brieuc 22023, France

La Seyne sur Mer, Hopital Chalucet, TOULON 83056, France

Hopital Michalon - C.H.U. de Grenoble, Grenoble 38043, France

Hopital Tenon, Paris 75970, France

Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon, PARIS 75679, France

C.H.U. Brabois - Tour Drouet, Rue du Morvan, Vandoeuvre 54511, France

CORE Center, Berlin 13353, Germany

Albrecht Ulmer, M.D., Stuttgart 70197, Germany

Institut fur Immunologie Pathologie und Molekularbiologie, Hamburg 20099, Germany

Universitatsklinikum, Dusseldorf 40225, Germany

Klinikum J.W. Goethe Universitat, Frankfurt 60596, Germany

S. Raffaele Hospital, Milan 20127, Italy

Wojewodzki Szpital Zakazny, Warszawa 01-201, Poland

Centro Familiar, Inc, Ponce 00731, Puerto Rico

New Puerto Rico CONCRA, Rio Piedras 00925, Puerto Rico

Hospital Clinic I Provincial, Barcelona 08036, Spain

Hospital De La Sta Creu I San Pau, Barcelona 08025, Spain

Hospital Germans Trias I Pujol, Badalona 08916, Spain

Hospital Universitario Vergen del Rocio, Sevilla 41013, Spain

Hospital La Paz, Madrid 28046, Spain

Hospital Carlos III, Madrid, 28010, Spain

Royal Free Hospital, London, NW3 2QG, United Kingdom

Phoenix Body Positive, Inc., Phoenix,, Arizona 85006, United States

AIDS Health Care Foundation - Research Center, Los Angeles, California 90027, United States

Paul J. Cimoch, M.D., Fountain Valley, California 92780, United States

Tower Infectious Diseases Medical Associates, Los Angeles, California 90048, United States

20th Avenue Medical Center Kaiser Permanente, Denver, Colorado 80205, United States

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

Associates in Research, Fort Myers, Florida 33901, United States

Gary J. Richmond, M.D., Ft. Lauderdale, Florida 33316, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Infectious Disease Research Institute, Inc., Tampa, Florida 33614, United States

University of Miami School of Medicine, Miami, Florida 33136, 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

Ottawa Hospital General Campus, Ottawa, Ontario K1H 8L6, Canada

Toronto General Hospital Division of The University Health Network, Toronto, Ontario M5G-2C4, Canada

The Research & Education Group, Portland, Oregon 97209, United States

Bornemann Internal Medicine, Reading, Pennsylvania 19601, United States

Montreal Chest Institute/Royal Victoria Hospital, Montreal, Quebec H2X 2PA, Canada

David Wright, M.D., Austin, Texas 78705, United States

Diversified Medical Practices, P.A., Houston, Texas 77027, United States

University of Texas Medical Branch, Galveston, Texas 77555-0435, United States

Hampton Roads Medical Specialists, Hampton, Virginia 23666, United States

Starting date: April 2001
Last updated: March 29, 2008