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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00004583 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects |
| Estimated Enrollment: | 660 |
| Study Start Date: | March 1999 |
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this trial if you:
Exclusion Criteria
You will not be eligible for this trial if you:
Contacts and Locations
Hide Study Locations| 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 | |
| Steinhart Medical Associates | |
| Miami, Florida, United States, 33133 | |
| 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 | |
| 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 | |
| East Orange Veterans Administration Med Ctr | |
| East Orange, New Jersey, United States, 07018 | |
| United States, New York | |
| 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, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75235 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| Oaklawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
| Joseph C Gathe | |
| Houston, Texas, United States, 77004 | |
| 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 | |
| Alfred Hosp | |
| Prahan, Australia | |
| Royal Brisbane Hosp | |
| Herston, Australia | |
| Royal Perth Hosp | |
| Perth, 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 | |
| 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 | |
| France | |
| Groupe Hospitalier Bichat-Claude Bernard | |
| Paris Cedex 18, France | |
| CHU De Bicetre | |
| Paris, France | |
| Centre Hospitalier De Compiegne | |
| Compiegne, France | |
| Hopital Paul Brousse | |
| Villejuif, 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 | |
| Poland | |
| Ctr of AIDS Diagnosis and Treatment | |
| Warszawa, Poland | |
| Puerto Rico | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 00909 | |
| South Africa | |
| Cyrildene | |
| Johannesburg, South Africa | |
| Miller | |
| Belford Gardens, South Africa | |
| Wits Medical School | |
| Parktown, 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 | |
| Imperial College School of Medicine | |
| London, United Kingdom | |
More Information
| Study ID Numbers: | 285C, M98-863 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004583 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Administration, Oral Stavudine HIV Protease Inhibitors Lamivudine |
Reverse Transcriptase Inhibitors Anti-HIV Agents Nelfinavir ABT 378 |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir 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 HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |
