LAAM-HAART PET Imaging
Completed · Early Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.
Key facts
- Study ID
- NCT01935830
- Run by
- Washington University School of Medicine
- People needed
- 10
- Starts
- 2013-08-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-12-13
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Subjects will not be enrolled if any of the following criteria exist:
- Known history of liver or kidney disease
- History of major medical conditions
- HIV seropositive
- Fasting blood glucose > 110 mg/dl (because HAART can cause glucose intolerance)
- Family history of type 2 diabetes
- 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)
- Females who are pregnant or nursing
- Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
- 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
- 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))
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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