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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00028301 |
Purpose
This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Lopinavir/Ritonavir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Randomized Open-Label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s) |
Eligibility| Ages Eligible for Study: | 16 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 | |
| Cooper Green Hosp | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| Saint Francis Mem Hosp / HIV Care Unit | |
| San Francisco, California, United States, 94109 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| United States, Colorado | |
| Beacon Clinic / Boulder Community Hosp | |
| Boulder, Colorado, United States, 80304 | |
| United States, Florida | |
| Community Health Care | |
| Fort Lauderdale, Florida, United States, 33306 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Florida ID Group | |
| Orlando, Florida, United States, 32801 | |
| Larry Bush | |
| Atlantis, Florida, United States, 33462 | |
| South Beach Medical Associates | |
| Miami Beach, Florida, United States, 33160 | |
| United States, Georgia | |
| Infectious Disease Specialists of Atlanta | |
| Decatur, Georgia, United States, 30033 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Idaho | |
| Sky Blue | |
| Boise, Idaho, United States, 83704 | |
| United States, Indiana | |
| Infectious Disease of Indiana | |
| Indianapolis, Indiana, United States, 46218 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 672143124 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Massachusetts | |
| Univ of Massachusetts | |
| Worcester, Massachusetts, United States, 01655 | |
| Community Research Initiative | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Missouri | |
| Southampton Healthcare Inc | |
| St Louis, Missouri, United States, 63139 | |
| United States, Nevada | |
| Steven Zell | |
| Reno, Nevada, United States, 89502 | |
| United States, New Jersey | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| VAMC New Jersey Healthcare System | |
| East Orange, New Jersey, United States, 07018 | |
| United States, New York | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| Community Health Network | |
| Rochester, New York, United States, 14620 | |
| Albany Med College | |
| Albany, New York, United States, 12208 | |
| Erie County Med Ctr | |
| Buffalo, New York, United States, 14215 | |
| United States, North Carolina | |
| Jemsek Clinic | |
| Huntersville, North Carolina, United States, 28078 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 97201 | |
| Research & Education Group | |
| Portland, Oregon, United States, 97209 | |
| United States, Pennsylvania | |
| Mark Watkins | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Univ of South Carolina School of Medicine | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Infectious Diseases Associates of Houston | |
| Houston, Texas, United States, 77030 | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77006 | |
| Nicholas Bellos | |
| Dallas, Texas, United States, 75246 | |
| North Texas Center for AIDS & Clinical Research | |
| Dallas, Texas, United States, 75208 | |
| Argentina | |
| CAICI | |
| Rosario Santa Fe, Argentina | |
| Fundacion Huesped | |
| Buenos Aires, Argentina | |
| Elida Pallone MD | |
| Buenos Aires, Argentina | |
| Claudia Rodriguez MD | |
| Buenos Aires, Argentina | |
| Hospital Italiano | |
| Buenos Aires, Argentina | |
| Australia | |
| Saint Vincent's Hosp Med Centre | |
| Sydney, Australia | |
| Alfred Hosp | |
| Prahan, Australia | |
| Prahran Market Clinic | |
| South Yarra, Australia | |
| Taylors Square Clinic | |
| Sydney, Australia | |
| Belgium | |
| CHU Saint Pierre | |
| Brussels, Belgium | |
| University Hospital Gent | |
| Gent, Belgium | |
| Domaine Universitaire Du SART-TILMAN | |
| Liege, Belgium | |
| Inst of Tropical Medicine | |
| Antwerpe, Belgium | |
| Cliniques Universitaires Saint Luc | |
| Bruxelles, Belgium | |
| Brazil | |
| Hospital de Clinicas da Universidade Federal do Parana | |
| Curitiba, Brazil | |
| Hospital Nossa Senhora da Conceicao-GCH | |
| Porto Alegre, Brazil | |
| Instituto de Infectologia Emilio Ribas | |
| Sao Paulo, Brazil | |
| Canada, Ontario | |
| Toronto Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Gen Hosp / Div of Clin Immuno and Allergy | |
| Montreal, Quebec, Canada | |
| Dr Roger P Leblanc | |
| Montreal, Quebec, Canada | |
| Clinique Medicale du Quartier Latin | |
| Montreal, Quebec, Canada | |
| Chile | |
| Fundacion Arriaran | |
| Santiago, Chile | |
| Hosp Sotero de Rio | |
| Santiago, Chile | |
| Finland | |
| Aurora Hospital | |
| Unknown, Finland | |
| France | |
| Services des Maladies Infectieuses | |
| Paris Cedex 12, France | |
| Hopital Cochin - Port Royal | |
| Paris, France | |
| Hopital Hotel Dieu de Lyon | |
| Lyon, France | |
| CHU De Bicetre | |
| Paris, France | |
| Hopital Gustave Dron | |
| Tourcoing, France | |
| Italy | |
| Ospedale Amedeo di Savoia | |
| Torino, Italy | |
| Ospedale S Orsola | |
| Bologna, Italy | |
| Ospedale Luigi Sacco Cargnel | |
| Milano, Italy | |
| Ospedale degli Infermi | |
| Rimini, Italy | |
| Ospedale Amedeo de Savoia | |
| Torino, Italy | |
| Ospedale S Raffaele | |
| Milano, Italy | |
| Cat All Immun Clin | |
| Roma, Italy | |
| Immunoligia Universita Cagliari | |
| Cagliari, Italy | |
| Reparto di Malattie Infettive | |
| Corso Svizzera, Italy | |
| Mexico | |
| Instituto Nacional de la Nutricion | |
| Mexico City, Mexico | |
| Hospital General | |
| Mexico City, Mexico | |
| Hospital Regional | |
| Mexico City, Mexico | |
| Hospital 1 ro de Octubre | |
| Mexico City, Mexico | |
| Netherlands | |
| Univ Medical Center Utrecht | |
| CX Utrecht, Netherlands | |
| Peru | |
| Hosp Nacional Cayetano Heredia | |
| Lima, Peru | |
| Hosp Guillermo Almenara-Medicina 1 | |
| Lima, Peru | |
| Poland | |
| Klinicka Chorobzkaznych AM | |
| Unknown, Poland | |
| Puerto Rico | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 009091711 | |
| San Cristobal Hosp | |
| Coto Laurel, Ponce, Puerto Rico, 00780 | |
| Spain | |
| Hosp Clinic | |
| Barcelona, Spain | |
| Hosp Carlos III | |
| Madrid, Spain | |
| Hosp Virgen Del Rocio | |
| Sevilla, Spain | |
| Hosp Ramon y Cajal | |
| Madris, Spain | |
| Hosp de Basurto / Enfermedades Infecciosas | |
| Bilboa, Spain | |
| Hosp Reina Sofia | |
| Cordoba, Spain | |
| Hosp Nuestra Senora de Covadonga | |
| Oviedo, Spain | |
| Hospital Germans Trias I Pujol | |
| Barcelona, Spain | |
| United Kingdom | |
| Royal Liverpool Univ Hosp | |
| Liverpool, United Kingdom | |
| Whittal Street Clinic | |
| Birmingham, United Kingdom | |
| Department of Infection & Tropical Medicine | |
| Unknown, United Kingdom | |
More Information
| Study ID Numbers: | 302D, AI424-043 |
| Study First Received: | December 20, 2001 |
| Last Updated: | March 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028301 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV Protease Inhibitors RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Lipids ABT 378 Antiretroviral Therapy, Highly Active Lipoproteins, LDL Cholesterol |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Lopinavir 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 Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |