18F-Raltegravir Distribution for HIV

Overseen By Timothy J Henrich, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Must not be taking: Immunomodulatory drugs

Disqualifiers: Serious illness, Pregnancy, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Timothy J Henrich, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 with HIV who are on ART regimens. They must have normal levels of neutrophils, platelets, hemoglobin, and liver enzymes, and not be severely ill or hospitalized recently. Pregnant or breastfeeding women can't join, nor those with certain metal implants incompatible with MRI.

Inclusion Criteria

HIV infection

You have started a combination therapy for HIV/AIDS treatment.

Exclusion Criteria

Screening absolute neutrophil count <1,000 cells/mm3

Screening platelet count <70,000 cells/mm3

Screening hemoglobin < 8 mg/dL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single microdose of 18F-raltegravir and undergo PET/MRI to determine drug distribution

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Raltegravir

Trial Overview The study tests how a microdose of the drug 18F-raltegravir spreads through the body in HIV patients using PET/MRI scans. It aims to understand the drug's distribution in tissues, especially within the lymphoreticular system.

Participant Groups

Group I: 18F-Raltegravir Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University