Overview

LAAM-HAART PET Imaging

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
Efavirenz
Methadyl Acetate
Ritonavir
Criteria
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))