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18F-Raltegravir Distribution for HIV

Q: Is there presently an opportunity to join this clinical experiment?

<p>Clinicaltrials.gov reports that this medical experiment, initially posted on April 1st 2018, is presently accepting applicants. Its most recent update was recorded as August 9th 2023.</p>

Q: How many participants are being accepted for this clinical trial?

<p>Affirmative. According to clinicaltrials.gov, the trial was first posted on 1st April 2018 and is currently recruiting for 10 participants at a single site. It has been recently updated as of 9th August 2023.</p>

Phase < 1

Recruiting

Led By Timothy J Henrich, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one imaging session within 1 to 6 hours following administration of 18f-raltegravir

Awards & highlights

Study Summary

This trial will study the distribution of a microdose of 18F-raltegravir given to HIV-infected subjects who are either taking or not taking a raltegravir-containing ART regimen.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a pharmacokinetic study focusing on drug distribution rather than treatment effects or efficacy, specific side effects of the microdosed radiolabeled raltegravir aren't detailed but may include reactions similar to standard raltegravir.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one imaging session within 1 to 6 hours following administration of 18f-raltegravir

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one imaging session within 1 to 6 hours following administration of 18f-raltegravir

This trial's timeline: 3 weeks for screening, Varies for treatment, and one imaging session within 1 to 6 hours following administration of 18f-raltegravir for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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.

Side effects data

From 2016 Phase 4 trial • 48 Patients • NCT01529749

20%

Hepatitis C

20%

Sexual transmitted diseases

10%

Post lumbar puncture headache

10%

Abdominal pain

100%

80%

60%

40%

20%

Study treatment Arm

FTC/TDF+MK-0518+Losartan

EFV/FTC/TDF + Losartan

FTC/TDF + MK-0518

EFV/FTC/TDF

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-RaltegravirExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,543 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,503 Previous Clinical Trials

15,236,645 Total Patients Enrolled

Timothy J Henrich, MDPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

18F-Raltegravir Clinical Trial Eligibility Overview. Trial Name: NCT03174977 — Phase < 1

HIV Research Study Groups: 18F-Raltegravir

HIV Clinical Trial 2023: 18F-Raltegravir Highlights & Side Effects. Trial Name: NCT03174977 — Phase < 1

18F-Raltegravir 2023 Treatment Timeline for Medical Study. Trial Name: NCT03174977 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there presently an opportunity to join this clinical experiment?

"Clinicaltrials.gov reports that this medical experiment, initially posted on April 1st 2018, is presently accepting applicants. Its most recent update was recorded as August 9th 2023."

Answered by AI

How many participants are being accepted for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial was first posted on 1st April 2018 and is currently recruiting for 10 participants at a single site. It has been recently updated as of 9th August 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics Distribution of Raltegravir by PET/MR

2018. "Pharmacokinetics Distribution of Raltegravir by PET/MR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03174977.