Understanding how Raltegravir distributes in the body using advanced imaging
Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study.
EARLY_PHASE1 · University of California, San Francisco · NCT03174977
This study is trying to see how a small dose of Raltegravir moves through the bodies of people with HIV to help improve future treatments.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | chemotherapy, methotrexate, prednisone |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03174977 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics and distribution of a microdose of 18F-raltegravir in HIV-infected individuals. Participants will receive an intravenous dose of the drug and then undergo PET/MRI scans to visualize how the drug spreads through the lymphoreticular system and other tissues. The study aims to gather data on the drug's behavior in the body, which could inform future treatment strategies for HIV. It includes both patients on and off a raltegravir-containing ART regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are HIV-infected and have initiated a combination ART regimen.
Not a fit: Patients with serious health issues, certain blood count abnormalities, or those on immunomodulatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of Raltegravir's distribution, potentially leading to improved treatment protocols for HIV.
How similar studies have performed: While studies on drug distribution in HIV treatment exist, this specific approach using PET/MRI with a microdose of Raltegravir is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Timothy J Henrich, MD — University of California, San Francisco
- Study coordinator: Timothy J Henrich, MD
- Email: timothy.henrich@ucsf.edu
- Phone: 415-206-5518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV-1-infection