NCT01935830

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at P25-P50 for early_phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2013

Typical duration for early_phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

August 30, 2013

Last Update Submit

December 11, 2017

Conditions

Healthy Volunteers

Keywords

PET ImagingEfavirenzRitonavior [11C] LAAMHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • cerebral [11C]LAAM distribution volume

    Blood tests, MRI and PET data analysis and interpretation

    approximately 3 months

Study Arms (1)

LAAM arm

EXPERIMENTAL

1. \[11C\]LAAM 15-20 mCi (maximum administered mass of 10 ug) 2. Efavirenz, oral capsules, 600 mg 3. Ritonavir, oral capsules, 100 mg

Radiation: [11c] LAAMDrug: RitonavirDrug: Efavirenz

Interventions

[11c] LAAMRADIATION

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

LAAM arm
RitonavirDRUG

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

Also known as: Kaletra
LAAM arm
EfavirenzDRUG

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

Also known as: Sustiva, Atripla
LAAM arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Methadyl AcetateRitonavirlopinavir-ritonavir drug combinationefavirenzEfavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

MethadoneKetonesOrganic ChemicalsThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTenofovirOrganophosphonatesOrganophosphorus CompoundsOxazinesEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Evan D Kharasch, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 5, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

December 13, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)