Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients

Exclusion Criteria

• •Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) that, in the opinion of the investigator, would preclude the patient from participating in the study.
• •Patient has an M184V mutation in reverse transcriptase, or mutations at 10, 20, 32, 46, 47, 48, 50, 54, 71, 73, 82, 84, or 90;
• •K65R mutation or 2 or more TAMs at baseline
• •History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.
• •Patient is either pregnant at time of screening evaluation or breast-feeding.
• •Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen.
• •Patient suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient
• •Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
• •Patient is undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
• •HBV coinfection
• •Patient has any of the following laboratory results within 30 days prior to the first dose of study medication: \*Hemoglobin concentration \< 8.0 g/dL; \*Absolute neutrophil count \< 750 cells/mm3; \*Platelet count \<50,000 cells/ mm3; \*Aminotransferase (AST, ALT) \>3 times ULN; \*Serum creatinine \>1.5 times the Upper Limits of Normal (ULN)
• •Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.
• •Patient requires treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, or interferon's within 4 weeks prior to study entry, or patients who have received an HIV immunotherapeutic vaccine within 3 months prior to entry. Asthmatic patients using inhaled corticosteroids are eligible for enrollment.
• •Patient receiving methadone therapy
• •Patients requiring foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
• •Patient prescribed/taking astemizole, terfenadine, cisapride, midazolam, triazolam, flecainide, pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or ergot derivatives
• •Patient has a history of allergy to any of the study drugs or any excipients therein.
• •In addition, patients non-compliant with study medication during 2 - 4 week study periods despite adherence counseling will not be retained in the study due to increased risk for selective pressure and potential development of protease resistance.
• •Patient requires inhaled or intranasal fluticasone.