LAAM-HAART PET Imaging

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935830
• Other study ID #: 201307040
• Status: Completed
• Phase: Early Phase 1
• First received: August 30, 2013
• Last updated: December 11, 2017
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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))

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Radiation:
• [11c] LAAM
intravenous administration of 15-20 mCi of [11c] LAAM.

Drug:
• Ritonavir
Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
• Efavirenz
Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral [11C]LAAM distribution volume	Blood tests, MRI and PET data analysis and interpretation	approximately 3 months