"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.

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

Details

• Lead Sponsor: Arribas, Jose R., M.D.
• Collaborators: Abbott; Pulido, Federico, M.D.
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• HIV patients > 18 years old who provide signed and dated Informed consent.

• HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.

• Plasma HIV RNA < 50 cop/ml for six months

Exclusion Criteria:

• HIV patients who have stopped a protease inhibitor due to virological failure.

• HIV patients with hepatic or renal insufficiency.

• HIV patients with positive serum HBVAg

• HIV patients who require treatment with a lopinavir/r contraindicated medication.

• HIV pregnant or breastfeeding women.

• Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.