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LAAM-HAART PET Imaging

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01935830
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
25
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: LAAM arm

[11C]LAAM 15-20 mCi (maximum administered mass of 10 ug) Efavirenz, oral capsules, 600 mg Ritonavir, oral capsules, 100 mg

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.
Other Names:
  • Kaletra

    • Drug: Efavirenz
    Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
    Other Names:
  • Sustiva, Atripla

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cerebral [11C]LAAM distribution volume [approximately 3 months]

      Blood tests, MRI and PET data analysis and interpretation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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))

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Evan D Kharasch, MD, PhD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01935830
    Other Study ID Numbers:
    • 201307040
    First Posted:
    Sep 5, 2013
    Last Update Posted:
    Dec 13, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Washington University School of Medicine
    PET Imaging
    Efavirenz
    Ritonavior [11C] LAAM
    Healthy volunteers
    Additional relevant MeSH terms:
    Ritonavir
    Efavirenz

    Study Results

    No Results Posted as of Dec 13, 2017