LAAM-HAART PET Imaging
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|ClinicalTrials.gov Identifier: NCT01935830|
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Radiation: [11c] LAAM Drug: Ritonavir Drug: Efavirenz||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||September 2015|
Experimental: LAAM arm
Radiation: [11c] LAAM
intravenous administration of 15-20 mCi of [11c] LAAM.
Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
Other Name: Kaletra
Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
Other Name: Sustiva, Atripla
- cerebral [11C]LAAM distribution volume [ Time Frame: approximately 3 months ]Blood tests, MRI and PET data analysis and interpretation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935830
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Evan D Kharasch, MD, PhD||Washington University School of Medicine|