A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered with Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral experienced, HIV-1 Infected Subjects. - ND

• Conditions: Treatment of HIV infection in antiretrovival-experienced HIV-1 infected subjects; MedDRA version: 8.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2006-000748-14-IT
• Lead Sponsor: Abbott GmBH Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Subject is at least 18 years of age. 2. Subject has voluntarily signed and dated an informed consent form 3. Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 weeks. 4. Subject has never received lopinavir/ritonavir. 5. Subject is currently failing his/her antiretroviral regimen with the most recent two consecutive pre-study plasma HIV-1 RNA levels 400 copies/mL with the most recent being 1000 copies/mL, and in the investigator s opinion, should change therapy. 6. Subject has plasma HIV-1 RNA levels 1000 copies/mL at Screening. 7. Based on HIV-1 drug resistance genotypic test results at the Screening Visit and prior treatment history, the investigator considers lopinavir/ritonavir plus at least two NRTIs to be an appropriate treatment for the subject. 8. Subject does not require and agrees not to take any antiretroviral medication except lopinavir/ritonavir and NRTIs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy / Breast feeding 2. Screening laboratory analyses show any of the following abnormal laboratory results 9679; Hemoglobin 8.0 g/dL 9679; Absolute neutrophil count 750 cells/mL 9679; Platelet count 50,000 mm3 9679; ALT SGOT or AST SGPT 5.0 Upper Limit of Normal ULN 3. Subject has a history of an allergic reaction or significant sensitivity to lopinavir or ritonavir. 4. Subject has an ongoing history of substance abuse recreational drugs, alcohol or psychiatric illness that could preclude adherence with the protocol. 5. Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic or hepatic disease that would adversely affect his/her participating in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified