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Pharmacokinetics Distribution of Raltegravir by PET/MR

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ClinicalTrials.gov Identifier: NCT03174977
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: 18F-Raltegravir Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 18F-Raltegravir Drug: 18F-Raltegravir
A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy.




Primary Outcome Measures :
  1. 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 [ Time Frame: One imaging session within 1 to 6 hours following administration of 18F-Raltegravir ]
  2. 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. [ Time Frame: One imaging session within 1 to 6 hours following administration of 18F-Raltegravir ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174977


Contacts
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Contact: Timothy J Henrich, MD 415-206-5518 timothy.henrich@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Timothy J Henrich, MD    415-206-5518    timothy.henrich@ucsf.edu   
Principal Investigator: Timothy J Henrich, MD         
Sub-Investigator: Henry F Vanbrocklin, PhD         
Sub-Investigator: Steven J Deeks, MD         
Sub-Investigator: Benajamin Franc, MD         
Sub-Investigator: Francesca Aweeka, PharmD         
Sponsors and Collaborators
University of California, San Francisco
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Timothy J Henrich, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03174977    
Other Study ID Numbers: 15-17586
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action