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To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging |
|
| Oral ritonavir | Active Comparator | Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging |
|
| Oral efavirenz | Active Comparator | Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C] desmethyl-loperamide | Drug | IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral [11C]dLop Distribution Volume | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Kharasch, MD, PhD. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PET/CT Imaging | Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging [11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging [11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cerebral [11C]dLop Distribution Volume | 0 Participants Analyzed/Assigned. The PI has left the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (no Pretreatment) | Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging [11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Kharasch MD PhD | Washington University | 3143628796 | kharasch@wustl.edu |
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| ID | Term |
|---|---|
| C419149 | N-demethylloperamide |
| D019438 | Ritonavir |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Control - no pretreatment | Other | Session 1: IV administration of 10-14 mCi [11C] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI |
|
| Oral ritonavir | Drug | 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 |
|
| Oral efavirenz | Drug | 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 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Oral Efavirenz | Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging [11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz |
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Oral Ritonvir | Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging [11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz | 0 | 13 | 0 | 13 | 2 | 13 |
| EG002 | Oral Efavirenz | Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging [11C] desmethyl-loperamide: IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz | 0 | 13 | 0 | 13 | 4 | 13 |
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Social circumstances | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |