Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue

NCT06132386 | Completed Results

• 3 other identifiers: IRB00307426R56AI161030-01A1R01AG064908-03
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Aging

Keywords

tenofovir; pharmacokinetic; cellular kinase

Outcome Measures

Primary Outcomes (3)

• Concentration of AK2 in Colorectal Tissue

  Concentration in nanometers (nm) of AK2 in colorectal tissue.

  Once within one month

• Concentration of CKM in Colorectal Tissue

  Concentration in nanometers (nm) of CKM in colorectal tissue

  Once within one month

• Concentration of AK2 in Peripheral Blood Mononuclear Cells

  Concentration in nanometers (nm) of AK2 in peripheral blood mononuclear cells

  Once within one month

Study Arms (3)

Healthy Volunteers, not taking Tenofovir (TFV) based PrEP

Other: biopsy

Healthy volunteers, steady state Tenofovir (TFV) based regimen

Other: biopsy

Persons infected with HIV taking Tenofovir (TFV) and emtricitabine (FTC) based HIV treatment

Other: biopsy

Interventions

biopsy OTHER

colorectal biopsy for tissue acquisition

Healthy Volunteers, not taking Tenofovir (TFV) based PrEP; Healthy volunteers, steady state Tenofovir (TFV) based regimen; Persons infected with HIV taking Tenofovir (TFV) and emtricitabine (FTC) based HIV treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population include adults between the ages of 18-50 and 65-80. The population recruited will include healthy volunteers and persons on HIV treatment or prevention that contains tenofovir.

You may qualify if:

• English speaking male or female volunteers between the ages of 18-50 for younger adults or 65-80 for older adults
• Willing to provide written informed consent
• Willing to abstain from insertion of anything in rectum for 72 hours before and 72 hours after the endoscopic procedure for colorectal tissue collection.
• Not currently participating in other research studies involving drugs and/or medical devices.
• For participants not infected with HIV (Control Cohort A)
• No known risk for HIV exposure or a documented negative HIV-1/HIV-2 Ag/Ab test in the past 3 months (HIV risk, but not on PrEP)
• Documented negative HBsAg in those taking study TFV (i.e. cohort B)
• For participants not infected with HIV, but taking or willing to take TFV (PrEP Cohort B)
• Currently taking TFV-based oral PrEP daily or willing to take oral TFV-containing PrEP for one week
• Documented negative HIV-1/HIV-2 Ag/Ab test in the past 3 months
• Documented negative HBsAg
• For participants infected with HIV (ARV Cohort C)
• Virologically suppressed HIV for at least 6 months prior to screening.
• Taking tenofovir disoproxil fumarate or tenofovir alafenamide containing regimen to treat HIV

You may not qualify if:

• History of inflammatory bowel disease or active inflammatory condition of the GI tract
• History of significant gastrointestinal bleeding
• Current medically-indicated use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], non-steroidal anti-inflammatory drugs \[NSAIDs\], or Pradaxa®)
• Use of systemic immunomodulatory medications within 4 weeks of enrollment
• Use of rectally administered medications within 4 weeks of enrollment
• Use of product containing nonoxynol-9 within 4 weeks of enrollment
• Use of any investigational products within 4 weeks of enrollment
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease.
• Active rectal infection (GC, Chlamydia, HSV). Participants screening positive for GC/CT at the time of endoscopy will be excluded from analysis (and replaced).
• For participants not undergoing a concurrent endoscopic procedure for indication unrelated to this study:
• Hct \<36%
• Platelet count \<150/mm3
• International normalised ratio blood test \> 1.2

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

rectal tissue and blood plasma

MeSH Terms

Conditions

HIV Infections

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Grant Principal Investigator
• Organization: Johns Hopkins University

chendrix@jhmi.edu

410-375-4418

Study Officials

• Craig Hendrix, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 15, 2023
• Study Start: August 7, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)