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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
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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