Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.

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

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Cobicistat; Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• documented HIV infection

• presence of HIV associated neurocognitive disorders requiring a lumbar puncture for clinical reasons

• treatment or qualifying to be treated with a HIV therapy including darunavir/r (800/100 mg once daily)

• ability to comply with the study requirements

• informed consent

Exclusion Criteria:

• conditions which disrupt the blood-brain barrier and thereby impact the entry of drugs in the brain (meningitis, meningoencephalitis, multiple sclerosis, progressive multifocal leucoencephalopathy)

• co-medications inhibiting/inducing P-glycoprotein and BCRP

• co-medications inhibiting/inducing cytochrome P450 isoenzyme 3A4 (CYP3A4)

• non adherence to Treatment

• pregnancy