NCT01668147

Efavirenz and Ritonavir on Human Brain P-Glycoprotein

Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

Detailed description

Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between

Conditions

• Drug Effects

Interventions

Type	Name	Description
DRUG	[11C] desmethyl-loperamide	IV administration of 10-14 mCi of \[11C\] desmethyl-loperamide with PET/CT imaging
OTHER	Control - no pretreatment	Session 1: IV administration of 10-14 mCi \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI
DRUG	Oral ritonavir	Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI
DRUG	Oral efavirenz	Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2012-08-17
• Last updated: 2020-01-22
• Results posted: 2020-01-22

Locations

1 site across 1 country: United States