Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Lipids, ABT 378, Antiretroviral Therapy, Highly Active, Lipoproteins, LDL Cholesterol
Eligibility 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.
Sites / Locations
- Cooper Green Hosp
- Phoenix Body Positive
- East Bay AIDS Ctr
- Saint Francis Mem Hosp / HIV Care Unit
- Kaiser Foundation Hospital
- San Francisco Veterans Administration Med Ctr
- Harbor UCLA Med Ctr
- Beacon Clinic / Boulder Community Hosp
- IDC Research Initiative
- Larry Bush
- Community Health Care
- South Beach Medical Associates
- Florida ID Group
- Infectious Disease Specialists of Atlanta
- Univ of Hawaii
- Sky Blue
- Infectious Disease of Indiana
- Univ of Kansas School of Medicine
- Univ of Kentucky Med Ctr
- Community Research Initiative
- Univ of Massachusetts
- Southampton Healthcare Inc
- Steven Zell
- VAMC New Jersey Healthcare System
- North Jersey Community Research Initiative
- Albany Med College
- Erie County Med Ctr
- North Shore Univ Hosp
- Community Health Network
- Jemsek Clinic
- Oregon Health Sciences Univ
- Research & Education Group
- Mark Watkins
- Univ of South Carolina School of Medicine
- North Texas Center for AIDS & Clinical Research
- Nicholas Bellos
- Houston Clinical Research Network
- Infectious Diseases Associates of Houston
- Claudia Rodriguez MD
- Elida Pallone MD
- Fundacion Huesped
- Hospital Italiano
- CAICI
- Alfred Hosp
- Prahran Market Clinic
- Saint Vincent's Hosp Med Centre
- Taylors Square Clinic
- Inst of Tropical Medicine
- CHU Saint Pierre
- Cliniques Universitaires Saint Luc
- University Hospital Gent
- Domaine Universitaire Du SART-TILMAN
- Hospital de Clinicas da Universidade Federal do Parana
- Hospital Nossa Senhora da Conceicao-GCH
- Instituto de Infectologia Emilio Ribas
- Toronto Hosp
- Clinique Medicale du Quartier Latin
- Dr Roger P Leblanc
- Montreal Gen Hosp / Div of Clin Immuno and Allergy
- Fundacion Arriaran
- Hosp Sotero de Rio
- Hopital Hotel Dieu de Lyon
- Services des Maladies Infectieuses
- CHU De Bicetre
- Hopital Cochin - Port Royal
- Hopital Gustave Dron
- Ospedale S Orsola
- Immunoligia Universita Cagliari
- Reparto di Malattie Infettive
- Ospedale Luigi Sacco Cargnel
- Ospedale S Raffaele
- Ospedale degli Infermi
- Cat All Immun Clin
- Ospedale Amedeo de Savoia
- Ospedale Amedeo di Savoia
- Hospital 1 ro de Octubre
- Hospital General
- Hospital Regional
- Instituto Nacional de la Nutricion
- Univ Medical Center Utrecht
- Hosp Guillermo Almenara-Medicina 1
- Hosp Nacional Cayetano Heredia
- San Cristobal Hosp
- Clinical Research Puerto Rico Inc
- Hosp Clinic
- Hospital Germans Trias I Pujol
- Hosp de Basurto / Enfermedades Infecciosas
- Hosp Reina Sofia
- Hosp Carlos III
- Hosp Ramon y Cajal
- Hosp Nuestra Senora de Covadonga
- Hosp Virgen Del Rocio
- Whittal Street Clinic
- Royal Liverpool Univ Hosp
- Aurora Hospital
- Department of Infection & Tropical Medicine
- Klinicka Chorobzkaznych AM