NCT04870671

Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor

Completed EARLY_PHASE1 Results posted Last updated 30 January 2024

What this trial tests

EARLY_PHASE1 trial testing Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) in HIV/AIDS in 14 participants. Completed in 31 January 2023.

Timeline

25 March 2021

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Eastern Virginia Medical School
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	14
Start date	25 March 2021
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Adherence, Medication — all drugs for Adherence, Medication →
• Drug Use — all drugs for Drug Use →

Sponsor

Eastern Virginia Medical School

Who can join

Adults 18 to 50, female only, with HIV/AIDS or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Adherence

Serious: 0/7 (0%)

Deaths: 0/7

Low Adherence

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (6 terms — click to expand)

Reaction	System	High Adherence	Low Adherence
Diarrhea	Gastrointestinal disorders	—	—
Nausea	General disorders	—	—
upper respiratory infection	Respiratory, thoracic and mediastinal disorders	—	—
increased appetite	General disorders	—	—
headache	General disorders	—	—
Allergies	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT04870671 adverse events section.

Sponsor's own description

Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in aptamer-based biosensing technology for isolation and detection of extracellular vesicles.
   Alnaser-Almusa O, Mahmoud M, Ilyas M, Adwan R, et al · · 2025 · cited 3× · PMID 40772226 · DOI 10.3389/fcell.2025.1555687
2. Surface Plasmon Resonance Aptasensors: Emerging Design and Deployment Landscape.
   Khalid-Salako F, Kurt H, Yüce M. · · 2025 · cited 2× · PMID 40558441 · DOI 10.3390/bios15060359
3. Are we there yet with XNA aptamers?
   Chaillou S, Thonon S, Reynders S, Lescrinier E, et al · · 2026 · PMID 42063527 · DOI 10.1039/d5ra05395a
4. Designing the Future of Biosensing: Advances in Aptamer Discovery, Computational Modeling, and Diagnostic Applications.
   Jesky RG, Lo LHY, Siu RHP, Tanner JA. · · 2025 · PMID 41149291 · DOI 10.3390/bios15100637