Actively Recruiting
Pharmacokinetics Distribution of Raltegravir by PET/MR
Led by University of California, San Francisco · Updated on 2024-06-18
10
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetics Distribution of Raltegravir by PET/MR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- HIV infection
- Initiated a combination ART (HAART) regimen
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
T
Timothy J Henrich, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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