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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00004581 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Nevirapine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Pacific Oaks Med Group | |
| Beverly Hills, California, United States, 90211 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| Orange County Ctr for Special Immunology | |
| Fountain Valley, California, United States, 92708 | |
| United States, Connecticut | |
| Yale Univ / AIDS Clinical Trials Unit | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Emory Univ | |
| Atlanta, Georgia, United States, 30308 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Division of Inf Diseases/ Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Michigan | |
| Univ of Michigan Hospitals and Health Ctrs | |
| Ann Arbor, Michigan, United States, 481090378 | |
| United States, Minnesota | |
| Abbott Northwestern Hosp | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New Jersey | |
| Saint Michael's Med Ctr / Dept of Infectious Diseases | |
| Newark, New Jersey, United States, 07102 | |
| St Michaels Med Ctr | |
| Newark, New Jersey, United States, 07102 | |
| United States, New York | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| Howard Grossman | |
| New York, New York, United States, 10011 | |
| SUNY at Stony Brook / Div of Infectious Disease | |
| Stony Brook, New York, United States, 117948153 | |
| Cornell Clinical Trials Unit - Chelsea Clinic | |
| New York, New York, United States, 10011 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Duke Univ Med Ctr / Infectious Disease Clinic | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Holmes Hosp / Univ of Cincinnati Med Ctr | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Oklahoma | |
| Associates in Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 972109951 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Stephen Hauptman | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| The Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75235 | |
| Oaklawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
| Univ of Texas / Med Branch at Galveston | |
| Galveston, Texas, United States, 775550835 | |
| Joseph C Gathe | |
| Houston, Texas, United States, 77004 | |
| United States, Utah | |
| Univ of Utah Med School / Clinical Trials Ctr | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| Univ of Virginia Health Sciences Ctr | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| Univ of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Australia | |
| Royal Brisbane Hosp | |
| Herston, Australia | |
| Austria | |
| Pulmologisches Zentrum Der Stadt Wien | |
| Wien, Austria | |
| Brazil | |
| Castelo | |
| Sao Paulo, Brazil | |
| Hosp Evandro Chagas Fioernz | |
| Manguinhos RJ, Brazil | |
| Hosp Do Servidor Publico Estadual De Sao Paulo | |
| Sao Paulo, Brazil | |
| Hosp Heliopolis | |
| Sao Paulo, Brazil | |
| Fundacao Zerbini Casa Da Aids | |
| Sao Paulo, Brazil | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Sunnybrook Health Science Ctr | |
| Toronto, Ontario, Canada | |
| Ottawa General Hospital | |
| Ottawa, Ontario, Canada | |
| Toronto Gen Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Chest Institute | |
| Montreal, Quebec, Canada | |
| Clinique Medicale L'Actuele | |
| Montreal, Quebec, Canada | |
| Clinique Medicale du Quartier Latin | |
| Montreal, Quebec, Canada | |
| Denmark | |
| Righospitalet | |
| Copenhagen, Denmark | |
| Hvidovre Univ Hosp | |
| Hvidovre, Denmark | |
| Odense Univ Hosp | |
| Odense C, Denmark | |
| France | |
| Groupe Hospitalier Bichat-Claude Bernard | |
| Paris Cedex 18, France | |
| CHU De Bicetre | |
| Paris, France | |
| Hopital Paul Brousse | |
| Villejuif, France | |
| Hopital Gustave Dron | |
| Tourcoing, France | |
| Germany | |
| Allgemeines Krankenhaus St Georg | |
| Hamburg, Germany | |
| Heinrich Heine Universitat | |
| Dusseldorf, Germany | |
| EPIMED | |
| Berlin, Germany | |
| Univ Zu Koeln | |
| Koeln, Germany | |
| Klinikum Der Johann Wolfgang Goethe Universitat | |
| Frankfurt, Germany | |
| Aids Study Group Mannheim | |
| Mannheim, Germany | |
| Poland | |
| Ctr of AIDS Diagnosis and Treatment | |
| Warszawa, Poland | |
| Puerto Rico | |
| Ponce Univ Hosp | |
| Ponce, Puerto Rico, 00731 | |
| South Africa | |
| Cyrildene | |
| Johannesburg, South Africa | |
| Miller | |
| Belford Gardens, South Africa | |
| Spain | |
| Hosp La Paz | |
| Madrid, Spain | |
| Hosp De Mostoles | |
| Madrid, Spain | |
| Hosp Germans Trias I Pujol | |
| Barcelona, Spain | |
| Hosp Carlos III | |
| Madrid, Spain | |
| Hosp Doce De Octubre | |
| Madrid, Spain | |
| Hosp Virgen Del Rocio | |
| Sevilla, Spain | |
| Switzerland | |
| Universitatsspital Zurich | |
| Zurich, Switzerland | |
| United Kingdom | |
| Royal Free Hosp | |
| London, United Kingdom | |
| Brighton Gen Hosp | |
| Brighton, United Kingdom | |
| Chelsea and Westminster Hosp | |
| London, United Kingdom | |
| Imperial College School of Medicine | |
| London, United Kingdom | |
More Information
| Study ID Numbers: | 285D, M98-888 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004581 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Nevirapine HIV Protease Inhibitors Ritonavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents ABT 378 |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Nevirapine HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |
