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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Lamivudine; Lopinavir; Reverse Transcriptase Inhibitors; Ritonavir; Stavudine

Criteria

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