Trial Outcomes & Findings for Efavirenz and Ritonavir on Human Brain P-Glycoprotein (NCT NCT01668147)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

1 day

Results posted on

2020-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	13
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Efavirenz and Ritonavir on Human Brain P-Glycoprotein

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm n=6 Participants 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
Age, Continuous	27 years STANDARD_DEVIATION 6 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Control (no Pretreatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Ritonvir

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Oral Efavirenz

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control (no Pretreatment) n=13 participants at risk 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	Oral Ritonvir n=13 participants at risk 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	Oral Efavirenz n=13 participants at risk 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
Gastrointestinal disorders nausea	0.00% 0/13	7.7% 1/13 • Number of events 1	0.00% 0/13
Skin and subcutaneous tissue disorders Rash	0.00% 0/13	0.00% 0/13	15.4% 2/13 • Number of events 2
Nervous system disorders Dizziness	0.00% 0/13	0.00% 0/13	23.1% 3/13 • Number of events 3
Social circumstances Anxiety	0.00% 0/13	7.7% 1/13 • Number of events 1	0.00% 0/13

Additional Information

Evan Kharasch MD PhD

Washington University

Phone: 3143628796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place