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LAAM-HAART PET Imaging

NCT ID: NCT01935830

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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PET Imaging Efavirenz Ritonavior [11C] LAAM Healthy volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

[11c] LAAM

Intervention Type RADIATION

intravenous administration of 15-20 mCi of \[11c\] LAAM.

Ritonavir

Intervention Type DRUG

Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of \[11c\] LAAM.

Efavirenz

Intervention Type DRUG

Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of \[11c\] LAAM.

Interventions

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[11c] LAAM

intravenous administration of 15-20 mCi of \[11c\] LAAM.

Intervention Type RADIATION

Ritonavir

Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of \[11c\] LAAM.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Kaletra Sustiva, Atripla

Eligibility Criteria

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Inclusion Criteria

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))
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evan D Kharasch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201307040

Identifier Type: -

Identifier Source: org_study_id