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Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) Clinical research trials and Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s). Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s) Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s)
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s)
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
Details: The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks. - Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization. - Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization. - Are at least 16 years old. - Have a documented virologic response to at least 1 HAART regimen. - Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC. - Have phenotypic sensitivity to atazanavir and LPV/RTV. - Use effective barrier methods of birth control. - Will be available for 48 weeks. Exclusion Criteria Patients will not be eligible for this study if they: - Have taken 2 or more PIs and had virologic failure. - Have taken atazanavir or LPV/RTV. - Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment. - Have had acute hepatitis in the 30 days prior to study entry. - Have received certain drugs within 3 months of study start or expect to need them at time of enrollment. - Abuse alcohol or drugs in a way that would interfere with the study. - Have very bad diarrhea within 30 days prior to study entry. - Are pregnant or breast-feeding. - Have a history of hemophilia. - Use lipid-lowering drugs (within the previous 30 days). - Have cardiomyopathy or symptoms of other heart disease. - Cannot take medicine by mouth. - Have any other condition that would interfere with the study. - Have pancreatitis, if choosing ddI as part of NRTI pair. - Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.
Total Enrollment:
Location and Contact Information:
Univ Medical Center Utrecht
CX Utrecht, ,
Netherlands
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46218
United States
CHU Saint Pierre
Brussels, ,
Belgium
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Hosp Sotero de Rio
Santiago, ,
Chile
Hospital Germans Trias I Pujol
Barcelona, ,
Spain
North Texas Center for AIDS & Clinical Research
Dallas, Texas, 75208
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Massachusetts
Worcester, Massachusetts, 01655
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Ospedale degli Infermi
Rimini, ,
Italy
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Hopital Cochin - Port Royal
Paris, ,
France
Cooper Green Hosp
Birmingham, Alabama, 35233
United States
Aurora Hospital
Unknown, ,
Finland
Ospedale S Raffaele
Milano, ,
Italy
Hosp de Basurto / Enfermedades Infecciosas
Bilboa, ,
Spain
Royal Liverpool Univ Hosp
Liverpool, ,
United Kingdom
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Community Research Initiative
Brookline, Massachusetts, 02445
United States
Dr Roger P Leblanc
Montreal, Quebec,
Canada
Southampton Healthcare Inc
St. Louis, Missouri, 63139
United States
Florida ID Group
Orlando, Florida, 32801
United States
Domaine Universitaire Du SART-TILMAN
LIEGE, ,
Belgium
Prahran Market Clinic
South Yarra, ,
Australia
Hosp Nacional Cayetano Heredia
Lima, ,
Peru
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, ,
Brazil
Hospital 1 ro de Octubre
Mexico City, ,
Mexico
Inst of Tropical Medicine
Antwerpe, ,
Belgium
Fundacion Huesped
Buenos Aires, ,
Argentina
Taylors Square Clinic
Sydney, ,
Australia
Hospital Nossa Senhora da Conceicao-GCH
Porto Alegre, ,
Brazil
Erie County Med Ctr
Buffalo, New York, 14215
United States
Oregon Health Sciences Univ
Portland, Oregon, 97201
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
United States
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec,
Canada
Houston Clinical Research Network
Houston, Texas, 77006
United States
Hospital General
Mexico City, ,
Mexico
San Cristobal Hosp
Coto Laurel, Ponce, , 00780
Puerto Rico
Sky Blue
Boise, Idaho, 83704
United States
Hospital Italiano
Buenos Aires, ,
Argentina
Clinical Research Puerto Rico Inc
San Juan, , 009091711
Puerto Rico
Whittal Street Clinic
Birmingham, ,
United Kingdom
Hosp Ramon y Cajal
Madris, ,
Spain
Elida Pallone MD
Buenos Aires, ,
Argentina
Hosp Nuestra Senora de Covadonga
Oviedo, ,
Spain
Alfred Hosp
Prahan, ,
Australia
Hosp Reina Sofia
Cordoba, ,
Spain
Hosp Virgen Del Rocio
Sevilla, ,
Spain
Cat All Immun Clin
Roma, ,
Italy
Ospedale Amedeo di Savoia
Torino, ,
Italy
Community Health Care
Ft. Lauderdale, Florida, 33306
United States
Clinique Medicale du Quartier Latin
Montreal, Quebec,
Canada
Larry Bush
Atlantis, Florida, 33462
United States
Infectious Diseases Associates of Houston
Houston, Texas, 77030
United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
United States
Instituto de Infectologia Emilio Ribas
Sao Paulo, ,
Brazil
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
United States
Hopital Gustave Dron
Tourcoing, ,
France
Jemsek Clinic
Huntersville, North Carolina, 28078
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
South Beach Medical Associates
Miami, Florida, 33160
United States
Nicholas Bellos
Dallas, Texas, 75246
United States
Ospedale Luigi Sacco Cargnel
Milano, ,
Italy
Services des Maladies Infectieuses
Paris Cedex 12, ,
France
Ospedale S Orsola
Bologna, ,
Italy
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
United States
University Hospital Gent
Gent, ,
Belgium
Fundacion Arriaran
Santiago, ,
Chile
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
United States
Immunoligia Universita Cagliari
Cagliari, ,
Italy
Toronto Hosp
Toronto, Ontario,
Canada
Hospital Regional
Mexico City, ,
Mexico
CHU De Bicetre
Paris, ,
France
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
CAICI
Rosario Santa Fe, ,
Argentina
Hosp Clinic
Barcelona, ,
Spain
Reparto di Malattie Infettive
Corso Svizzera, ,
Italy
Mark Watkins
Philadelphia, Pennsylvania, 19107
United States
Hosp Guillermo Almenara-Medicina 1
Lima, ,
Peru
Univ of South Carolina School of Medicine
Columbia, South Carolina, 29203
United States
Klinicka Chorobzkaznych AM
Unknown, ,
Poland
Department of Infection & Tropical Medicine
Unknown, ,
United Kingdom
Cliniques Universitaires Saint Luc
BRUXELLES, ,
Belgium
Steven Zell
Reno, Nevada, 89502
United States
Instituto Nacional de la Nutricion
Mexico City, ,
Mexico
Research & Education Group
Portland, Oregon, 97209
United States
Hosp Carlos III
Madrid, ,
Spain
Claudia Rodriguez MD
Buenos Aires, ,
Argentina
Hopital Hotel Dieu de Lyon
Lyon, ,
France
Albany Med College
Albany, New York, 12208
United States
Community Health Network
Rochester, New York, 14620
United States
Ospedale Amedeo de Savoia
Torino, ,
Italy
Saint Vincent's Hosp Med Centre
Sydney, ,
Australia
Additional Information:
Study ID Numbers: 302D; AI424-043
Study Start Date: February 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028301
Other Hiv Infections Studies:
1. A Study of CI-1012 in HIV-Infected Patients
2. Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
3. Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients with AIDS or Advanced ARC who Cannot be Maintained on Zidovudine ( AZT ) Therapy.
4. A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS
5. Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
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Other Montreal Clinical Trials
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s)
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