A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
2 other identifiers
interventional
300
13 countries
87
Brief Summary
The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 20, 2009
February 1, 2009
November 2, 1999
February 19, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are at least 12 years old.
- Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
- Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
- Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
- Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have an active illness.
- Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
- Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
- Have received treatment with a PI other than their current PI.
- Are receiving chemotherapy for cancer.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (88)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Pacific Oaks Med Group
Beverly Hills, California, 90211, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Infectious Disease Research Institute
Tampa, Florida, 33614, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445, United States
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, 481090378, United States
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407, United States
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, 07102, United States
St Michaels Med Ctr
Newark, New Jersey, 07102, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011, United States
Howard Grossman
New York, New York, 10011, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153, United States
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, 27710, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Oregon Health Sciences Univ
Portland, Oregon, 972109951, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Stephen Hauptman
Philadelphia, Pennsylvania, 19107, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
Oaklawn Physicians Group
Dallas, Texas, 75219, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235, United States
Univ of Texas / Med Branch at Galveston
Galveston, Texas, 775550835, United States
Joseph C Gathe
Houston, Texas, 77004, United States
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, 84108, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908, United States
Univ of Wisconsin
Madison, Wisconsin, 53792, United States
Royal Brisbane Hosp
Herston, Australia
Pulmologisches Zentrum Der Stadt Wien
Vienna, Austria
Hosp Evandro Chagas Fioernz
Manguinhos RJ, Brazil
Castelo
São Paulo, Brazil
Fundacao Zerbini Casa Da Aids
São Paulo, Brazil
Hosp Do Servidor Publico Estadual De Sao Paulo
São Paulo, Brazil
Hosp Heliopolis
São Paulo, Brazil
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Righospitalet
Copenhagen, Denmark
Hvidovre Univ Hosp
Hvidovre, Denmark
Odense Univ Hosp
Odense C, Denmark
CHU De Bicetre
Paris, France
Groupe Hospitalier Bichat-Claude Bernard
Paris, France
Hopital Gustave Dron
Tourcoing, France
Hopital Paul Brousse
Villejuif, France
EPIMED
Berlin, Germany
Univ Zu Koeln
Cologne, Germany
Heinrich Heine Universitat
Düsseldorf, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, Germany
Allgemeines Krankenhaus St Georg
Hamburg, Germany
Aids Study Group Mannheim
Mannheim, Germany
Ctr of AIDS Diagnosis and Treatment
Warsaw, Poland
Ponce Univ Hosp
Ponce, 00731, Puerto Rico
Miller
Belford Gardens, South Africa
Cyrildene
Johannesburg, South Africa
Hosp Germans Trias I Pujol
Barcelona, Spain
Hosp Carlos III
Madrid, Spain
Hosp De Mostoles
Madrid, Spain
Hosp Doce De Octubre
Madrid, Spain
Hosp La Paz
Madrid, Spain
Hosp Virgen Del Rocio
Seville, Spain
Universitatsspital Zurich
Zurich, Switzerland
Brighton Gen Hosp
Brighton, United Kingdom
Chelsea and Westminster Hosp
London, United Kingdom
Imperial College School of Medicine
London, United Kingdom
Royal Free Hosp
London, United Kingdom