Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2 NRTIs+LPV/r therapy in patients failing a standard NNRTI-based treatment regimen as an interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization. Last, to define risk factors for monotherapy failure in HIV-treated individuals

Hypothesis. The rate of virologic suppression is not inferior in the monotherapy arm.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: National Health Security Office, Thailand; Swiss HIV Cohort Study
• Treatments: Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• HIV seropositive.

• Have had NNRTI-based HAART in the past for at least 6 months

• Naïve to protease inhibitors (PIs)

• Plasma HIVRNA ≥ 1000 copies/ml

• Signed written informed consent

Exclusion Criteria:

• Active AIDS-defining disease or active opportunistic infection

• Previously treated with PIs

• Pregnancy (negative pregnancy test for women of childbearing potential at screening).

• Documented chronic hepatitis B (HbsAg positive)

• ALT ≥ 200 U/L

• Creatinine clearance < 60 c.c. per min by Cockroft-Gault formula formula

• Use of medication that interfere with the action of LPV/r