Pharmacokinetics Distribution of Raltegravir by PET/MR

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03174977
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2018
Status verified
Jun 2024
Primary completion
Nov 1, 2024
Completion
Jan 1, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 18F-Raltegravir

Primary Outcome Measure

Number of patients with microdose (<2.5 millicurie; mCi) 18F-Raltegravir-related adverse events as measured by clinical observation during single intravenous dose administration and PET/MR imaging [ Time Frame: One imaging session within 1 to 6 hours following administration of 18F-Raltegravir ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110
Timothy J Henrich, MD
[email protected]
415-206-5518
Timothy J Henrich, MD (PRINCIPAL_INVESTIGATOR)
Henry F Vanbrocklin, PhD (SUB_INVESTIGATOR)
Steven J Deeks, MD (SUB_INVESTIGATOR)
Benajamin Franc, MD (SUB_INVESTIGATOR)
Francesca Aweeka, PharmD (SUB_INVESTIGATOR)

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