Pharmacokinetics Distribution of Raltegravir by PET/MR
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | April 1, 2018 |
| End Date: | January 1, 2019 |
| Contact: | Timothy J Henrich, MD |
| Email: | timothy.henrich@ucsf.edu |
| Phone: | 415-206-5518 |
Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study.
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.
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.
Inclusion Criteria:
- Age ≥18 years
- HIV infection
- Initiated a combination ART (HAART) regimen
Exclusion Criteria:
- 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.
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Timothy J Henrich, MD
Phone: 415-206-5518
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