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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Raltegravir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Raltegravir | Drug | A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy J Henrich, MD | Contact | 415-206-5518 | timothy.henrich@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Timothy J Henrich, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94110 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 2, 2025 | |
| Reset | Jun 17, 2025 | |
| Release | Aug 12, 2025 | |
| Reset | Aug 28, 2025 | |
| Release | Dec 19, 2025 | |
| Reset | Jan 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2025 | Jun 17, 2025 | |||
| Aug 12, 2025 |
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| Aug 28, 2025 |
| Dec 19, 2025 | Jan 13, 2026 |