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Efavirenz and Ritonavir on Human Brain P-Glycoprotein

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ClinicalTrials.gov Identifier: NCT01668147
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : June 22, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

July 30, 2012
August 17, 2012
June 22, 2018
August 2012
June 2016   (Final data collection date for primary outcome measure)
cerebral [11C]dLop distribution volume [ Time Frame: approximately 3 months ]
cerebral [11C]dLop distribution volume [ Time Frame: approximately 3 months ]
blood tests and PET data analysis and interpretation.
Complete list of historical versions of study NCT01668147 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efavirenz and Ritonavir on Human Brain P-Glycoprotein
Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.
Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between
Interventional
Not Applicable
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Drug Effects
Drug: [11C] desmethyl-loperamide
IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging after control, ritonavir or efavirenz
Experimental: study arm
Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging
Intervention: Drug: [11C] desmethyl-loperamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
8
August 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-pregnant female, 18-40 yr old
  • Good general health with no remarkable medical conditions
  • BMI < 33
  • Provide informed consent

Exclusion Criteria:

  • Known history of liver or kidney disease
  • History of major medical conditions
  • HIV seropositive
  • Fasting blood glucose > 110 mg/dl
  • 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 activity (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
  • Contraindications to PET scanning
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01668147
201205135
No
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Evan Kharasch, MD, PhD. Washington University School of Medicine
Washington University School of Medicine
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP