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LAAM-HAART PET Imaging

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ClinicalTrials.gov Identifier: NCT01935830
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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
Healthy Volunteers Radiation: [11c] LAAM Drug: Ritonavir Drug: Efavirenz Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LAAM arm
  1. [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
  2. Efavirenz, oral capsules, 600 mg
  3. 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 Name: 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 Name: Sustiva, Atripla




Primary Outcome Measures :
  1. cerebral [11C]LAAM distribution volume [ Time Frame: approximately 3 months ]
    Blood tests, MRI and PET data analysis and interpretation



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935830


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Evan D Kharasch, MD, PhD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01935830     History of Changes
Other Study ID Numbers: 201307040
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Methadyl Acetate
Ritonavir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents