Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.

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

Details

• Lead Sponsor: Daniel Podzamczer
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Patients older than 18, HIV positive

• Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months

• Undetectable viral load (<40 copies/ml) during the last 6 months

• Patients that accept participation in the study and sign the Informed Consent Form

• Childbearing females with negative pregnancy tests and using appropriate contraceptive measures

Exclusion Criteria:

• Opportunistic disease, cancer or any other active disease with specific treatment

• Active addiction to illegal drugs or active use of psychotropic drugs

• Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved > 3 months)

• Females who are breastfeeding or pregnant