LAAM-HAART PET Imaging



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:12/15/2017
Start Date:August 2013
End Date:September 2015

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

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


Inclusion

Each subject must meet all of the following criteria:

1. Male or non-pregnant female volunteer, 18-50 yr old

2. Good general health with no known major medical conditions

3. BMI < 33

4. Provide informed consent

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

1. Known history of liver or kidney disease

2. History of major medical conditions

3. HIV seropositive

4. Fasting blood glucose > 110 mg/dl (because HAART can cause glucose intolerance)

5. Family history of type 2 diabetes

6. 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)

7. Females who are pregnant or nursing

8. Females taking hormonal contraceptives who are unwilling to use alternative means of
contraception

9. 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

10. 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))
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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