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

NCT00038532 | Completed Phase 2

• 1 other identifier: M01-287
• Study Type: interventional
• Target: 24
• Locations: 11 countries
• Sites: 54

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.

Conditions

HIV Infections

Keywords

treatment experienced; HIV

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

Amprenavir/ritonavir DRUG

Saquinavir/ritonavir DRUG

Efavirenz DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (54)

Phoenix Body Positive, Inc.

Phoenix, Arizona, 85006, United States

Location

Paul J. Cimoch, M.D.

Fountain Valley, California, 92780, United States

Location

AIDS Health Care Foundation - Research Center

Los Angeles, California, 90027, United States

Location

Tower Infectious Diseases Medical Associates

Los Angeles, California, 90048, United States

Location

20th Avenue Medical Center Kaiser Permanente

Denver, Colorado, 80205, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

IDC Research Initiative

Altamonte Springs, Florida, 32701, United States

Location

Gary J. Richmond, M.D.

Fort Lauderdale, Florida, 33316, United States

Location

Associates in Research

Fort Myers, Florida, 33901, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Infectious Disease Research Institute, Inc.

Tampa, Florida, 33614, United States

Location

AIDS Research Consortium of Atlanta, Inc.

Atlanta, Georgia, 30308, United States

Location

CORE Center

Chicago, Illinois, 60612, United States

Location

Donna E. Sweet, M.D.

Wichita, Kansas, 67214, United States

Location

David Parks, M.D.

St Louis, Missouri, 63139, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Howard A. Grossman, M.D.

New York, New York, 10011, United States

Location

John B. Montana, M.D.

New York, New York, 10011, United States

Location

State University of New York at Stony Brook

Stony Brook, New York, 11794-08153, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0405, United States

Location

The Research & Education Group

Portland, Oregon, 97209, United States

Location

Bornemann Internal Medicine

Reading, Pennsylvania, 19601, United States

Location

David Wright, M.D.

Austin, Texas, 78705, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0435, United States

Location

Diversified Medical Practices, P.A.

Houston, Texas, 77027, United States

Location

Hampton Roads Medical Specialists

Hampton, Virginia, 23666, United States

Location

Hospital Muniz - FUNDAI

Buenos Aires, 4304-2180, Argentina

Location

Fundacion Huesped

Buenos Aires, 4981-1855, Argentina

Location

Hospital Heliopolis

São Paulo, 01332-000, Brazil

Location

Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hospital Division of The University Health Network

Toronto, Ontario, M5G-2C4, Canada

Location

Montreal Chest Institute/Royal Victoria Hospital

Montreal, Quebec, H2X 2PA, Canada

Location

Hopital Michalon - C.H.U. de Grenoble

Grenoble, 38043, France

Location

Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon

Paris, 75679, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hospital Yves Le Foll

Saint-Brieuc, 22023, France

Location

La Seyne sur Mer, Hopital Chalucet

Toulon, 83056, France

Location

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

Vandœuvre-lès-Nancy, 54511, France

Location

CORE Center

Berlin, 13353, Germany

Location

Universitatsklinikum

Düsseldorf, 40225, Germany

Location

Klinikum J.W. Goethe Universitat

Frankfurt, 60596, Germany

Location

Institut fur Immunologie Pathologie und Molekularbiologie

Hamburg, 20099, Germany

Location

Albrecht Ulmer, M.D.

Stuttgart, 70197, Germany

Location

S. Raffaele Hospital

Milan, 20127, Italy

Location

Wojewodzki Szpital Zakazny

Warsaw, 01-201, Poland

Location

Centro Familiar, Inc

Ponce, 00731, Puerto Rico

Location

New Puerto Rico CONCRA

Rio Piedras, 00925, Puerto Rico

Location

Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital De La Sta Creu I San Pau

Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital Carlos III

Madrid, 28010, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Vergen del Rocio

Seville, 41013, Spain

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

amprenavir; Ritonavir; Saquinavir; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Study Officials

• Eugene Sun, M.D.

  Divisional Vice President, Infectious Diseases and Virology Development

  STUDY CHAIR

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: April 1, 2008

Record last verified: 2006-07

Locations

GB (1); US (26); BR (1); DE (5); AR (2); IT (1); PL (1); PR (2); FR (6); CA (3); ES (6)