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Pharmacokinetics Distribution of Raltegravir by PET/MR

NCT03174977 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-06-18

No results posted yet for this study

Summary

This is a single-center drug distribution and pharmacokinetic study of a single microdose of 18F-raltegravir given to 10 HIV-infected subjects who are either taking or not taking a raltegravir-containing ART regimen. After administration of IV 18F-raltegravir, subjects will undergo PET/MRI in order to determine the distribution of radiolabeled drug through the lymphoreticular system and other tissues throughout the entire body.

Conditions

Interventions

DRUG

18F-Raltegravir

A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy.

Sponsors & Collaborators

Principal Investigators

  • Timothy J Henrich, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2024-11-01
Completion
2025-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174977 on ClinicalTrials.gov