Pharmacokinetics Distribution of Raltegravir by PET/MR

Last updated: June 14, 2024
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

18F-Raltegravir

Clinical Study ID

NCT03174977
15-17586
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • HIV infection

  • Initiated a combination ART (HAART) regimen

Exclusion

Exclusion Criteria:

  • Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000cells/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 thepreceding 3 months.

  • Any vaccination 2 weeks prior to baseline (Day 0) visit and throughout the studyperiod.

  • Concurrent treatment with immunomodulatory drugs, or exposure to anyimmunomodulatory drug in the preceding 16 weeks (e.g. corticosteroid therapy equalto 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 nasalsteroid use is not exclusionary.

  • Pregnant or breastfeeding women. Females of childbearing potential must have anegative serum pregnancy test at screening and agree to use a double-barrier methodof contraception throughout the study period.

  • Have a cardiac pacemaker or other indwelling foreign object that are contraindicatedfor MR imaging.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: 18F-Raltegravir
Phase: 1
Study Start date:
April 01, 2018
Estimated Completion Date:
January 01, 2025

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94110
    United States

    Active - Recruiting

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