A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
- Conditions
- HIV Infections
- Registration Number
- NCT00004583
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).
Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.
- Detailed Description
Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.
Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (83)
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Oaklawn Physicians Group
🇺🇸Dallas, Texas, United States
Abbott Northwestern Hosp
🇺🇸Minneapolis, Minnesota, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Toronto Gen Hosp
🇨🇦Toronto, Ontario, Canada
Hosp De Mostoles
🇪🇸Madrid, Spain
Stephen Hauptman
🇺🇸Philadelphia, Pennsylvania, United States
EPIMED
🇩🇪Berlin, Germany
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Hosp La Paz
🇪🇸Madrid, Spain
Klinikum Der Johann Wolfgang Goethe Universitat
🇩🇪Frankfurt, Germany
Hosp Virgen Del Rocio
🇪🇸Sevilla, Spain
Heinrich Heine Universitat
🇩🇪Dusseldorf, Germany
Univ Zu Koeln
🇩🇪Koeln, Germany
Montreal Chest Institute
🇨🇦Montreal, Quebec, Canada
Ctr of AIDS Diagnosis and Treatment
🇵🇱Warszawa, Poland
Wits Medical School
🇿🇦Parktown, South Africa
Clinique Medicale L'Actuele
🇨🇦Montreal, Quebec, Canada
Righospitalet
🇩🇰Copenhagen, Denmark
Hvidovre Univ Hosp
🇩🇰Hvidovre, Denmark
Groupe Hospitalier Bichat-Claude Bernard
🇫🇷Paris Cedex 18, France
Cyrildene
🇿🇦Johannesburg, South Africa
Centre Hospitalier De Compiegne
🇫🇷Compiegne, France
Miller
🇿🇦Belford Gardens, South Africa
Hopital Paul Brousse
🇫🇷Villejuif, France
CHU De Bicetre
🇫🇷Paris, France
Allgemeines Krankenhaus St Georg
🇩🇪Hamburg, Germany
Brighton Gen Hosp
🇬🇧Brighton, United Kingdom
Hosp Carlos III
🇪🇸Madrid, Spain
Hosp Germans Trias I Pujol
🇪🇸Barcelona, Spain
Imperial College School of Medicine
🇬🇧London, United Kingdom
Hosp Doce De Octubre
🇪🇸Madrid, Spain
Royal Free Hosp
🇬🇧London, United Kingdom
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
Steinhart Medical Associates
🇺🇸Miami, Florida, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Yale Univ / AIDS Clinical Trials Unit
🇺🇸New Haven, Connecticut, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Infectious Disease Research Institute
🇺🇸Tampa, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Community Research Initiative of New England
🇺🇸Brookline, Massachusetts, United States
Univ of Michigan Hospitals and Health Ctrs
🇺🇸Ann Arbor, Michigan, United States
East Orange Veterans Administration Med Ctr
🇺🇸East Orange, New Jersey, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Cornell Clinical Trials Unit - Chelsea Clinic
🇺🇸New York, New York, United States
Howard Grossman
🇺🇸New York, New York, United States
SUNY at Stony Brook / Div of Infectious Disease
🇺🇸Stony Brook, New York, United States
Duke Univ Med Ctr / Infectious Disease Clinic
🇺🇸Durham, North Carolina, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Oregon Health Sciences Univ
🇺🇸Portland, Oregon, United States
The Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Hosp Evandro Chagas Fioernz
🇧🇷Manguinhos RJ, Brazil
Central Texas Med Foundation
🇺🇸Austin, Texas, United States
Univ of Texas Southwestern Med Ctr
🇺🇸Dallas, Texas, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Royal Brisbane Hosp
🇦🇺Herston, Australia
Pulmologisches Zentrum Der Stadt Wien
🇦🇹Wien, Austria
Joseph C Gathe
🇺🇸Houston, Texas, United States
Alfred Hosp
🇦🇺Prahan, Australia
Univ of Virginia Health Sciences Ctr
🇺🇸Charlottesville, Virginia, United States
Royal Perth Hosp
🇦🇺Perth, Australia
Univ of Wisconsin
🇺🇸Madison, Wisconsin, United States
Hosp Do Servidor Publico Estadual De Sao Paulo
🇧🇷Sao Paulo, Brazil
Fundacao Zerbini Casa Da Aids
🇧🇷Sao Paulo, Brazil
Castelo
🇧🇷Sao Paulo, Brazil
Hosp Heliopolis
🇧🇷Sao Paulo, Brazil
Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States