Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen
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Switching patients with HIV infection from tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF) based drug regimen can provide many safety benefits including preserving bone mineral density and kidney function. This study will examine metabolic changes that patients may encounter due to the switch in medication regimens and the maintenance of viral suppression.
Condition or disease
HIV-1-infectionMetabolic SyndromeCardiovascular DiseasesWeight GainRenal Function AbnormalHyperglycemia
Patients with HIV infection who are virally suppressed receiving a tenofovir disoproxil fumarate-based antiretroviral therapy regimen that switched to tenofovir alafenamide without switching any other components of their treatment regimen.
Changes in weight will be determined through comparisons of average baseline and endpoint weights
Changes in metabolic syndrome [ Time Frame: 1 year ]
Changes in the presence of metabolic syndrome will be determined through comparisons of baseline and endpoint modified metabolic syndrome diagnostic criteria defined by the American Heart Association.
Changes in glycemic control [ Time Frame: 1 year ]
Changes in glycemic control will be determined through comparisons of baseline and endpoint fasting blood glucose and hemoglobin A1C levels
Changes in kidney function [ Time Frame: 1 year ]
Changes in kidney function will be determined through comparisons of baseline and endpoint creatinine clearance estimations.
Changes in cholesterol [ Time Frame: 1 year ]
Changes in cholesterol will be determined through comparisons of baseline and endpoint total cholesterol levels.
Changes in 10-year cardiovascular disease risk [ Time Frame: 1 year ]
Each patient's estimated 10-year cardiovascular disease risk will be calculated at baseline and endpoint after the ART regimen switch using the ASCVD scoring system.
Secondary Outcome Measures :
Treatment success [ Time Frame: 1 year ]
Patients will meet criteria for treatment success after their ART regimen switch if they maintain viral suppression and adherence to their TAF regimen for 12 months without having to incur additional ART switches due to toxicity, poor tolerability, cost restriction or access limitations.
Subgroup analyses will be performed to investigate factors associated with a lack of treatment success, if present, including the presence of a boosting agent within the ART regimen.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults living with HIV infection who are on antiretroviral therapy and virally suppressed who have switched one medication within their treatment regimen for safety reasons.
Patients with HIV who are virally suppressed receiving a tenofovir disoproxil fumarate-based antiretroviral therapy regimen that switched to tenofovir alafenamide without switching any other components of their medications.
Patients are excluded if their switch was prior to 2015