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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

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

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03174977
Phase
Phase 1
Lead Scientist
Timothy Henrich
Study Type
Interventional
Last Updated
May 1, 2017
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