PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03729752
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [89]Zr-DFO-VRC-HIVMAB060-00-AB — DRUG
    Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1.

Study Details

This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and temporal tissue uptake/tissue distribution of 89Zr-DFO-VRC01. This is not a treatment study of the biological activity of 89Zr-DFO-VRC01 to impact HIV persistence.

Key Dates

Start date
Nov 1, 2018
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Healthy Volunteer
    Four serial PET-MR scans over 120 hours following a single, bolus injection of \[89\]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).
  • Experimental: Viremic HIV-infected
    Four serial PET-MR scans over 120 hours following a single, bolus injection of \[89\]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).
  • Experimental: Suppressed HIV-infected
    A PET-MR scan following a single, bolus injection of \[89\]Zr-DFO-VRC-HIVMAB060-00-AB (89Zr-DFO-VRC01).

Primary Outcome Measure

Dosimetry of 89Zr-DFO-VRC01 in healthy volunteers and HIV-infected participants. [ Time Frame: 120 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110
Emily Fehrman, BS
[email protected]
415-476-4082

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