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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06132386
Study type Observational
Source Johns Hopkins University
Contact
Status Completed
Phase
Start date August 7, 2023
Completion date May 20, 2024

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