Recruiting
Early Phase 1

Raltegravir

Sponsor:

UCLA

Code:

NCT03174977

Conditions

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-Raltegravir

Study Details

Brief 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.

Conditions

HIV-1-infection

Study ID

NCT03174977

Start date

Apr 1, 2018

Status verified date

Jun, 2024

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Nov 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 18F-Raltegravir

Interventions

18F-Raltegravir

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

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Timothy J Henrich, MD

415-206-5518timothy.henrich@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Timothy J Henrich, MD

415-206-5518timothy.henrich@ucsf.edu

Principal Investigator:

Timothy J Henrich, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2024-06-18.