Pharmacokinetics Distribution of Raltegravir by PET/MR

NCT03174977 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 15-17586
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• 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

  One imaging session within 1 to 6 hours following administration of 18F-Raltegravir

• Whole-body distribution (coronal through pelvis) of radiolabeled 18F-Raltegravir as determined by PET-MR scanning and quantification of radiographic regions of interest (ROI) immediately following and up to 4 hours after drug administration.

  One imaging session within 1 to 6 hours following administration of 18F-Raltegravir

Study Arms (1)

18F-Raltegravir

EXPERIMENTAL

Drug: 18F-Raltegravir

Interventions

18F-Raltegravir DRUG

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

18F-Raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• HIV infection
• Initiated a combination ART (HAART) regimen

You may not qualify if:

• Screening absolute neutrophil count \<1,000 cells/mm3, platelet count \<70,000 cells/mm3, hemoglobin \< 8 mg/dL, estimated creatinine clearance \<40 mL/minute, aspartate aminotransferase \>100 units/L, alanine aminotransferase \>100 units/L.
• Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
• Any vaccination 2 weeks prior to baseline (Day 0) visit and throughout the study period.
• Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
• Have a cardiac pacemaker or other indwelling foreign object that are contraindicated for MR imaging.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

Study Officials

• Timothy J Henrich, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy J Henrich, MD

CONTACT

415-206-5518; timothy.henrich@ucsf.edu

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: March 3, 2017
• First Posted: June 5, 2017
• Study Start: April 1, 2018
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (1)