Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study.
Who is this study for? Patients with HIV-1
What treatments are being studied? 18F-Raltegravir
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• HIV infection
• Initiated a combination ART (HAART) regimen
Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Timothy J Henrich, MD
timothy.henrich@ucsf.edu
415-206-5518
Time Frame
Start Date: 2018-04-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 10
Treatments
Experimental: 18F-Raltegravir
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Merck Sharp & Dohme LLC