Pharmacokinetics Distribution of Raltegravir by PET/MR

University of California San Francisco (UCSF)

Status and phase: Enrolling; Early Phase 1

Conditions: HIV-1-infection

Treatments: Drug: 18F-Raltegravir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03174977

15-17586

Details and patient eligibility

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

18F-Raltegravir

Experimental group

Treatment:

Drug: 18F-Raltegravir