LAAM-HAART PET Imaging

Early Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Radiation: [11c] LAAM; Drug: Ritonavir; Drug: Efavirenz

• Registration Number: NCT01935830
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-05
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAAM arm	[11c] LAAM	1. \[11C\]LAAM 15-20 mCi (maximum administered mass of 10 ug) 2. Efavirenz, oral capsules, 600 mg 3. Ritonavir, oral capsules, 100 mg
LAAM arm	Ritonavir	1. \[11C\]LAAM 15-20 mCi (maximum administered mass of 10 ug) 2. Efavirenz, oral capsules, 600 mg 3. Ritonavir, oral capsules, 100 mg
LAAM arm	Efavirenz	1. \[11C\]LAAM 15-20 mCi (maximum administered mass of 10 ug) 2. Efavirenz, oral capsules, 600 mg 3. Ritonavir, oral capsules, 100 mg

Primary Outcome Measures

Name	Time	Method
cerebral [11C]LAAM distribution volume	approximately 3 months	Blood tests, MRI and PET data analysis and interpretation

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States