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Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen

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ClinicalTrials.gov Identifier: NCT03646370
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
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 Intervention/treatment
HIV-1-infection Metabolic Syndrome Cardiovascular Diseases Weight Gain Renal Function Abnormal Hyperglycemia Drug: Tenofovir Alafenamide

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : July 24, 2019
Estimated Study Completion Date : July 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Drug: Tenofovir Alafenamide
    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.


Primary Outcome Measures :
  1. Changes in weight [ Time Frame: 1 year ]
    Changes in weight will be determined through comparisons of average baseline and endpoint weights

  2. 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.

  3. 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

  4. Changes in kidney function [ Time Frame: 1 year ]
    Changes in kidney function will be determined through comparisons of baseline and endpoint creatinine clearance estimations.

  5. Changes in cholesterol [ Time Frame: 1 year ]
    Changes in cholesterol will be determined through comparisons of baseline and endpoint total cholesterol levels.

  6. 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 :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients are excluded if their switch was prior to 2015

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646370


Locations
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United States, Pennsylvania
Thomas Jeffeson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jason J Schafer, PharmD    215-503-7522    jason.schafer@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University

Publications:
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Erratum in: Circulation. 2015 Dec 22;132(25):e396.

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03646370     History of Changes
Other Study ID Numbers: 18G.433
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Hyperglycemia
Weight Gain
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Tenofovir
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents