Clinical Trials Directory

Trials / Completed

CompletedNCT06132386

Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue

Status
Completed
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

The goal of this clinical study is to learn about the effect of aging on certain enzymes, or proteins, in the blood and colon. The study involves collection of blood and colon tissue biopsies using a flexible sigmoidoscope or colonoscope. This study is also investigating how medications tenofovir and emtricitabine interact with certain enzymes. The investigators will compare the difference in enzyme activity between people taking tenofovir and emtricitabine, to those who are not taking tenofovir and emtricitabine.

Detailed description

This project involves obtaining peripheral blood mononuclear cells (PBMCs) and colorectal tissue samples from study participants in order to measure adenylate kinase 2 (AK2) and muscle-type creatine kinase (CKM) enzyme levels in various age populations. Both AK2 and CKM has been demonstrated to be vital enzymes in converting the prodrug tenofovir (TFV) into its active form, tenofovir diphosphate (TFV-DP). However, no study has yet investigated the effect of aging on AK2 or CKM in tissues relevant to HIV infection and prevention. This study will investigate the AK2 and CKM variability in individuals from various age groups and how the pharmacokinetics (PK) of tenofovir (TFV) vary with altering levels of cellular enzymes in different age populations

Conditions

Interventions

TypeNameDescription
OTHERbiopsycolorectal biopsy for tissue acquisition

Timeline

Start date
2023-08-07
Primary completion
2024-05-20
Completion
2024-05-20
First posted
2023-11-15
Last updated
2025-12-24
Results posted
2025-12-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06132386. Inclusion in this directory is not an endorsement.