LAAM-HAART PET Imaging

Study Overview
=================
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.

Official Title
-----------------
Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Radiation: [11c] LAAM
* Drug: Ritonavir
* Drug: Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Each subject must meet all of the following criteria: Male or non-pregnant female volunteer, 18-50 yr old Good general health with no known major medical conditions BMI < 33 Provide informed consent Exclusion Criteria Subjects will not be enrolled if any of the following criteria exist: Known history of liver or kidney disease History of major medical conditions HIV seropositive Fasting blood glucose > 110 mg/dl (because HAART can cause glucose intolerance) Family history of type 2 diabetes Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A (hormonal birth control medications are acceptable if alternative means of contraception are used) Females who are pregnant or nursing Females taking hormonal contraceptives who are unwilling to use alternative means of contraception Contraindications to MRI (e.g., metal implants or splinters in the body; a worn or implanted medical device, such as a pacemaker or drug pump; inability to lie flat for up to one hour; claustrophobia) or contraindications to PET scanning (e.g., inability to lie flat for up to one hour, claustrophobia, current Current or recent (within 12 months prior to screening) participation in research studies involving radiation exposure such that the total research-related radiation dose to the subject in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1))

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAAM arm<br>[11C]LAAM 15-20 mCi (maximum administered mass of 10 ug) Efavirenz, oral capsules, 600 mg Ritonavir, oral capsules, 100 mg | Radiation: [11c] LAAM<br>* intravenous administration of 15-20 mCi of [11c] LAAM.<br>Drug: Ritonavir<br>* Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.<br>* Other names: Kaletra;Drug: Efavirenz<br>* Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.<br>* Other names: Sustiva, Atripla;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral [11C]LAAM distribution volume | Blood tests, MRI and PET data analysis and interpretation | approximately 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET Imaging, Efavirenz, Ritonavior [11C] LAAM, Healthy volunteers