ClinicalTrials.gg
Sign In
Status unknownNCT03174977Updated Jun 18, 2024

Pharmacokinetics Distribution of Raltegravir by PET/MR

An Early Phase 1 interventional study of 18F-Raltegravir in HIV-1-infection, sponsored by University of California, San Francisco. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by University of California, San Francisco · Early Phase 1, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV-1-infection
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.

Browse University of California, San Francisco studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • HIV infection
  • Initiated a combination ART (HAART) regimen

Exclusion criteria

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    18F-Raltegravir

    Drug: 18F-Raltegravir

Interventions

  • Drug18F-Raltegravir

    A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy.

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • University of California, San Francisco
    San Francisco, California 94110, United States
    • Timothy J Henrich, MD · Contact · timothy.henrich@ucsf.edu · 415-206-5518
    • Timothy J Henrich, MD · Principal investigator
    • Henry F Vanbrocklin, PhD · Sub investigator
    • Steven J Deeks, MD · Sub investigator
    • Benajamin Franc, MD · Sub investigator
    • Francesca Aweeka, PharmD · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2018 (actual). Primary completion is estimated for Nov 2024, 79 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2017
First posted
Jun 5, 2017
StartActual
Apr 1, 2018
Primary completionEst.
Nov 1, 2024
CompletionEst.
Jan 1, 2025
Last update
Jun 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03174977
Lead sponsor
University of California, San Francisco
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 5, 2017
Start date
Apr 1, 2018
Primary completion
Nov 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Jun 18, 2024

Study contacts

Timothy J Henrich, MD
Contact
timothy.henrich@ucsf.edu
415-206-5518
Timothy J Henrich, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of California, San Francisco →

Start the discussion