ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.

Inclusion Criteria

• HIV-1 positive
• antiretroviral-adult males
• non-pregnant
• non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill

Exclusion Criteria

• History of:

  • prior antiretroviral therapy
  • significant drug hypersensitivity
  • psychiatric illness that precludes compliance
  • an active substance abuser
  • positive test results for drug abuse
  • abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
  • pregnancy or lactating female
  • received another investigational drug within 28 days of study initiation
  • unlikely to comply or unsuitable candidate in the opinion of the investigator