An observational study in HIV/AIDS and Adherence, Medication, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by University of Colorado, Denver · Observational
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.
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 84 is below the median of 239 across 367 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
PLWH who are initiating/re-initiating or have been on TAF for > 6 months.
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Exclusion Criteria:
A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort.
Device: Digital Pill
A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort.
Device: Digital Pill
Digital Pill over encapsulating tenofovir alafenamide ART
Also known as: etectRx ID-Cap System
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.
Time frame: Week 12
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.
Time frame: Week 16
Plan to share: No
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
University of Colorado, Denver →