Pharmacokinetics Distribution of Raltegravir by PET/MR
Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study.
University of California, San Francisco
10 participants
Apr 1, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Age ≥18 years
- HIV infection
- Initiated a combination ART (HAART) regimen
Exclusion Criteria6
- 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.
Interventions
A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03174977