Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

Completed · Phase 3

Conditions studied: HIV Infections

In brief

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

Key facts

Study ID

NCT00028301

Run by

Bristol-Myers Squibb

Starts

2001-02-01

Expected to finish

2003-09-01

Last updated by the study team

2010-09-13

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• East Bay AIDS Ctr — Berkeley, California, United States
• Saint Francis Mem Hosp / HIV Care Unit — San Francisco, California, United States
• Kaiser Foundation Hospital — San Francisco, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Beacon Clinic / Boulder Community Hosp — Boulder, Colorado, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Larry Bush — Atlantis, Florida, United States
• Community Health Care — Fort Lauderdale, Florida, United States
• South Beach Medical Associates — Miami Beach, Florida, United States
• Florida ID Group — Orlando, Florida, United States
• Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Sky Blue — Boise, Idaho, United States
• Infectious Disease of Indiana — Indianapolis, Indiana, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Univ of Kentucky Med Ctr — Lexington, Kentucky, United States
• Community Research Initiative — Brookline, Massachusetts, United States
• Univ of Massachusetts — Worcester, Massachusetts, United States
• Southampton Healthcare Inc — St Louis, Missouri, United States
• Steven Zell — Reno, Nevada, United States
• VAMC New Jersey Healthcare System — East Orange, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Cooper Green Hosp — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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