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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Atazanavir; Drug: Lopinavir/Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00028301

302D

AI424-043

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.