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Completed

NCT Number: NCT01668147

Efavirenz and Ritonavir on Human Brain P-Glycoprotein

To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

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Key information

Conditions

Drug Effects

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

[11C] desmethyl-loperamide

Drug

IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging

Control - no pretreatment

Other

Session 1: IV administration of 10-14 mCi [11C] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI

Oral ritonavir

Drug

Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi [11C]dLop with PET/CT imaging and brain MRI

Oral efavirenz

Drug

Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi [11C]dLop with PET/CT imaging and brain MRI

Primary outcomes

  1. Cerebral [11C]dLop Distribution Volume

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2012
Registry last updated
Jan 22, 2020

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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