Pharmacokinetics Distribution of Raltegravir by PET/MR
Early Phase 1
Recruiting
- Conditions
- HIV-1-infection
- Interventions
- Drug: 18F-Raltegravir
- Registration Number
- NCT03174977
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-Raltegravir 18F-Raltegravir -
- Primary Outcome Measures
Name Time Method Number of patients with microdose (<2.5 millicurie; mCi) 18F-Raltegravir-related adverse events as measured by clinical observation during single intravenous dose administration and PET/MR imaging One imaging session within 1 to 6 hours following administration of 18F-Raltegravir Whole-body distribution (coronal through pelvis) of radiolabeled 18F-Raltegravir as determined by PET-MR scanning and quantification of radiographic regions of interest (ROI) immediately following and up to 4 hours after drug administration. One imaging session within 1 to 6 hours following administration of 18F-Raltegravir
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States