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18F-Raltegravir Distribution for HIV

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 up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
0%
Study treatment Arm
FTC/TDF+MK-0518+Losartan
EFV/FTC/TDF + Losartan
FTC/TDF + MK-0518
EFV/FTC/TDF

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-RaltegravirExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,323 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,166 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
~1 spots leftby Nov 2025
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