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
| Type | Name | Description |
|---|---|---|
| OTHER | biopsy | colorectal 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.