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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI145453-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort. |
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| Group 2 | A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Pill | Device | Digital Pill over encapsulating tenofovir alafenamide ART |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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PLWH who are initiating/re-initiating or have been on TAF for > 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Peter L Anderson, PharmD | University of Colorado-AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38636950 | Derived | Coyle RP, Morrow M, Mann SC, Mainella V, Ellis SL, Schwab S, Coppinger C, Barker N, Ellison L, Zheng JH, Al Zuabi S, Alpert PE, Carnes TC, Buffkin DE Jr, Chai PR, Bushman LR, Kiser JJ, MaWhinney S, Brooks KM, Anderson PL, Castillo-Mancilla JR. Tenofovir-Diphosphate and Emtricitabine-Triphosphate Adherence Benchmarks in Dried Blood Spots for Persons With HIV Receiving Tenofovir Alafenamide and Emtricitabine-Based Antiretroviral Therapy (QUANTI-TAF). Clin Infect Dis. 2024 Nov 22;79(5):1233-1241. doi: 10.1093/cid/ciae212. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Whole blood
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |