HIV InfectionsNCT06132386
Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue
An observational study of HIV Infections and Aging, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Aging
- What is being tested?
- biopsy
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 20 May 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- HIV Infections, Aging
- Being tested
- biopsy
- Keywords
- tenofovir, pharmacokinetic, cellular kinase
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
colorectal biopsy for tissue acquisition
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers, not taking Tenofovir (TFV) based PrEP | Not described Receives: Other: biopsy | |
| Healthy volunteers, steady state Tenofovir (TFV) based regimen | Not described Receives: Other: biopsy | |
| Persons infected with HIV taking Tenofovir (TFV) and emtricitabine (FTC) based HIV treatment | Not described Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of AK2 in Colorectal Tissue
Concentration in nanometers (nm) of AK2 in colorectal tissue.
Measured: Once within one month
Concentration of CKM in Colorectal Tissue
Concentration in nanometers (nm) of CKM in colorectal tissue
Measured: Once within one month
Concentration of AK2 in Peripheral Blood Mononuclear Cells
Concentration in nanometers (nm) of AK2 in peripheral blood mononuclear cells
Measured: Once within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start7 Aug 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Craig Hendrix, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132386
- Sponsor's protocol ID
- IRB00307426
- Other IDs
- R56AI161030-01A1, R01AG064908-03
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2023
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue
- ClinicalTrials.gov ID
- NCT06132386
- Acronym / sponsor ID
- IRB00307426
- Conditions
- HIV Infections, Aging
- Keywords
- tenofovir, pharmacokinetic, cellular kinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsycolorectal biopsy for tissue acquisition | Other | 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 |
Primary outcome
Concentration of AK2 in Colorectal Tissue
Time frame: Once within one month
Concentration in nanometers (nm) of AK2 in colorectal tissue.
Concentration of CKM in Colorectal Tissue
Time frame: Once within one month
Concentration in nanometers (nm) of CKM in colorectal tissue
Concentration of AK2 in Peripheral Blood Mononuclear Cells
Time frame: Once within one month
Concentration in nanometers (nm) of AK2 in peripheral blood mononuclear cells
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Hendrix, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Aging, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of AK2 in Colorectal Tissue (time frame: Once within one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.