A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules

Inclusion Criteria:

• Ability and willingness of subject or legal guardian/representative to give written informed consent.
• HIV-1 infected.
• At least 18 years of age
• Have the last two HIV-1 RNA measurements performed prior to screening be <50 or 75 copies/mL within the last 180 days, as well as at the time of screening.
• No evidence of primary PI mutations (defined by IAS-USA) documented on previous resistance testing, if ever performed and available, or suggested to be present by previous treatment history.

• Laboratory values:

  • Absolute neutrophil count (ANC) >500/mm3.

• -Hemoglobin >7.0 g/dL.

  • platelet count >50,000/mm3.
  • AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 X ULN.
  • Total bilirubin <2.5 x ULN, unless on IDV or ATV in which case must be <1.5 x ULN of direct bilirubin.
  • Calculated creatinine clearance >50 mL/min as estimated by the Cockcroft-Gault equation
• For women of reproductive potential, negative serum or urine pregnancy test within 7 days prior to initiating study medications. If participating in sexual activity that could lead to pregnancy, female study subjects must use two forms of contraception, one of which must be a barrier method. All subjects must continue to use contraception for 6 weeks after stopping the study medications.
• Willingness to take an alcohol containing product.
• Karnofsky performance score >70.

Exclusion Criteria:

• Pregnancy or breast-feeding
• Greater than Grade 1 diarrhea or nausea (as defined by protocol)
• Use of a NNRTI within 12 weeks of screening
• Use of antimotility or antiemetics during the 14 days prior to screening
• Use of any of the prohibited medications (defined by protocol) within 30 days of study entry.
• Need to continue the use of prohibited or select precautionary medications (defined by protocol)
• Known hypersensitivity to lopinavir/ritonavir
• Active drug or alcohol use or dependence which, in the Investigator’s opinion, may interfere with adherence to study requirements or endanger subject’s health while on the study
• Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry.
• Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to study entry.
• Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV-1 vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry