Conditions: Drug Effects
Keywords: PET Imaging Efavirenz Ritonavir [11C] desmethyl-loperamide Healthy volunteers
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 13
Healthy volunteers: yes

Brief 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

Arms:
arm 1: Session 1: Control (no pretreatment) - IV 10-14 mCi of \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging arm 2: Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of \[11C\]dLop with PET/CT imaging arm 3: Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of \[11C\]dLop with PET/CT imaging

Interventions: intervention 1: [11C] desmethyl-loperamide intervention 2: Control - no pretreatment intervention 3: Oral ritonavir intervention 4: Oral efavirenz
Intervention descriptions: intervention 1: IV administration of 10-14 mCi of \[11C\] desmethyl-loperamide with PET/CT imaging intervention 2: Session 1: IV administration of 10-14 mCi \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI intervention 3: 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 intervention 4: 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

Protocol document: