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

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; HIV Protease Inhibitors; Lopinavir; Protease Inhibitors; Ritonavir

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.