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Completed

NCT Number: NCT01935830

LAAM-HAART PET Imaging

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion

Each subject must meet all of the following criteria:

  • Male or non-pregnant female volunteer, 18-50 yr old
  • Good general health with no known major medical conditions
  • BMI < 33
  • Provide informed consent

Exclusion criteria

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))

Treatment and study plan

[11c] LAAM

Radiation

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

Ritonavir

Drug

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

Other names: Kaletra

Efavirenz

Drug

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

Primary outcomes

  1. cerebral [11C]LAAM distribution volume

    Time frame: approximately 3 months

    Blood tests, MRI and PET data analysis and interpretation

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2013
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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