HIV/AIDS Clinical Trial
Official title:
Quantification of Tenofovir Alafenamide Adherence and Exposure in Adults Living With HIV
Verified date | September 2023 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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 |
Status | Clinical Trial | Phase | |
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