Pharmacokinetics Distribution of Raltegravir by PET/MR

a study on HIV/AIDS HIV-Associated Dementia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Timothy J Henrich, MD (ucsf)

Description

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.

Official Title

Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study.

Keywords

HIV-1-infection, Raltegravir Potassium, 18F-Raltegravir

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join 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.
  • Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in the preceding 16 weeks (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon-alpha, methotrexate, cancer chemotherapy). NOTE: Use of inhaled or nasal steroid use is not exclusionary.
  • 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.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94110 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03174977
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated