Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

HIV/AIDS Clinical Trial

Official title:

Quantification of Tenofovir Alafenamide Adherence and Exposure in Adults Living With HIV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04065347
• Other study ID #: 19-0715
• Secondary ID: 1R01AI145453-01A
• Status: Active, not recruiting
• Start date: November 21, 2019
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being done to evaluate the relationship between adherence to antiretroviral therapy (ART) and HIV drug concentrations in persons living with HIV (PLWH) that are taking tenofovir alafenamide (TAF). Adherence will be measured with an ingestible biosensor (digital pill). Antiretroviral drug concentrations will be measured in different types of blood cells.

Description:

PLWH taking or initiating/re-initiating TAF will be recruited for a 16-week study. Upon entering the study, participants will be trained on the use the digital pill to objectively quantify adherence. Study participants already taking TAF will return every 4 weeks for a study visit where blood for drug concentrations will be obtained. Participants initiating/re-initiating TAF will return weekly for the first 4 weeks, at weeks 6 and 8, and every 4 weeks thereafter for a study visit where drug concentrations will be obtained.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Females or males with HIV, able to give informed consent and comply with study procedures.

2. Currently on (> 6 months), or planning to initiate/re-initiate TAF.

Exclusion Criteria:

1. For females of childbearing age, active pregnancy or any intent to become pregnant

2. Hepatitis C (HCV) infection for which treatment is anticipated within the next 16 weeks after enrollment. Treated HCV with sustained virologic response is allowable if last dose of HCV antivirals was >12 months prior to enrollment

3. Advanced renal (eGFR <30 mL/min/1.73m**2) or liver (Child-Pugh B or C) disease

4. History of extensive bowel surgery, gastric bypass, or gastroparesis

5. Concomitant use of any prescription or non-prescription drug known (or with the potential) to significantly influence the PK of TAF (e.g. rifamycins, carbamazepine, phenytoin, St. John's Wort, tipranavir)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence, Medication
• HIV Infections
• HIV/AIDS

Intervention

Device:
• Digital Pill
Digital Pill over encapsulating tenofovir alafenamide ART

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)	Steady-state drug concentration distribution and quantiles for highly adherent (i.e. >95% of ingestions) participants.	Week 12
Primary	Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)	Steady-state drug concentration distribution and quantiles for highly adherent (i.e. >95% of ingestions) participants.	Week 16