We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy (2104)

This study is currently recruiting participants.
Verified October 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02012621
First Posted: December 16, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a TFV-based regimen. Using DBS will allow the investigators to assess this simple method to measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP levels will be lowest in individuals with a detectable viral load and highest in those with viral suppression.

Condition
HIV/AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with HIV viral suppression at study visit #1 (initial study visit). [ Time Frame: Study Visit #1 (at enrollment) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with HIV viral suppression at study visit #2. [ Time Frame: Study Visit #2 (3-6 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with HIV viral suppression at study visit #3. [ Time Frame: Study Visit #3 (8-12 months after study visit #1) ]

Secondary Outcome Measures:
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with self-reported adherence at study visit #1 (initial study visit). [ Time Frame: Study Visit #1 (at enrollment) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with self-reported adherence at study visit #2. [ Time Frame: Study Visit #2 (3-6 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with self-reported adherence at study visit #3. [ Time Frame: Study Visit #3 (8-12 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with pharmacy refill adherence at study visit #1 (initial study visit). [ Time Frame: Study Visit #1 (at enrollment) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with pharmacy refill adherence at study visit #2. [ Time Frame: Study Visit #2 (3-6 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with pharmacy refill adherence at study visit #3. [ Time Frame: Study Visit #3 (8-12 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with and elevation in serum creatinine at study visit #1 (initial study visit). [ Time Frame: Study Visit #1 (at enrollment) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with and elevation in serum creatinine at study visit #2. [ Time Frame: Study Visit #2 (3-6 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with and elevation in serum creatinine at study visit #3. [ Time Frame: Study Visit #3 (8-12 months after study visit #1) ]
  • Level of TFV-DP in DBS in participants with wild-type vs. single nucleotide polymorphisms in ABCC2 (-24C>T, 1249G>A), ABCC4 (1612C>T, 3463G>A, 3724G>A, 4131T>G), and other relevant genes for tenofovir at study visit #1 (initial study visit). [ Time Frame: Study Visit #1 (at enrollment) ]
  • Level of TFV-DP in DBS in participants with wild-type vs. single nucleotide polymorphisms in ABCC2 (-24C>T, 1249G>A), ABCC4 (1612C>T, 3463G>A, 3724G>A, 4131T>G), and other relevant genes for tenofovir at study visit #2. [ Time Frame: Study Visit #2 (3-6 months after study visit #1) ]
  • Level of TFV-DP in DBS in participants with wild-type vs. single nucleotide polymorphisms in ABCC2 (-24C>T, 1249G>A), ABCC4 (1612C>T, 3463G>A, 3724G>A, 4131T>G), and other relevant genes for tenofovir at study visit #3. [ Time Frame: Study Visit #3 (8-12 months after study visit #1) ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) at study visit #1 associated with HIV viral suppression at study visits #2 and #3. [ Time Frame: Study Visit #1 (at enrollment), Study Visit #2 (3-6 months after study visit #1) and Study Visit #3 (8-12 months after study visit #1). ]
  • Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) at study visit #2 associated with HIV viral suppression at study visit #3. [ Time Frame: Study Visit #2 (3-6 months after study visit #1) and Study Visit #3 (8-12 months after study visit #1). ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Estimated Enrollment: 1000
Study Start Date: December 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Detailed Description:

Antiretroviral drug exposure is directly linked to individual host factors which include age, weight, diet, and genetics. However, the main factor impacting long-term drug exposure is drug adherence. Adherence is a strong predictor of HIV treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. To date, no gold standard measure to monitor antiretroviral exposure and adherence has been applied in clinical practice. Tenofovir (TFV) and its active metabolite, tenofovir diphosphate (TFV-DP), have distinctive pharmacological characteristics that make them ideal candidates for drug adherence and exposure monitoring. The long half life (~14-17 days) of TFV-DP in red blood cells (RBC) are properties well suited for monitoring average dose exposure over time. Based on these, the investigators propose that RBC levels of TFV-DP are an accurate and precise measure of long-term drug exposure in HIV-infected individuals. In addition, the investigators aim to quantify TFV-DP in dried blood spots (DBS) as a simple method to measure drug exposure.

This is an observational, 48-week prospective study of HIV-infected individuals treated with TFV in which the investigators will compare DBS TFV-DP levels in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict virologic failure and also drug toxicity. To accomplish this, the investigators will approach HIV-infected patients currently taking TFV (which is being prescribed by a primary care physician) and who present to the clinic for regular HIV care. After informed consent is obtained, the investigators will collect extra blood samples for DBS TFV-DP and obtain information on drug adherence. The investigators will also collect extra blood samples for DBS TFV-DP at each subject's subsequent visit for approximately 3 visits in a 48 week period of time.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected individuals who are taking tenofovir.
Criteria

Inclusion Criteria:

  • HIV-infected individual.
  • 18 years and older.
  • Taking tenofovir.
  • Blood drawn during regular clinic visit.

Exclusion Criteria:

  • Refusal to participate.
  Contacts and Locations
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): NCT02012621


Contacts
Contact: Jose R. Castillo-Mancilla, MD 303-724-4934 jose.castillo-mancilla@ucdenver.edu

Locations
United States, Colorado
University of Colorado-Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Jose R. Castillo-Mancilla, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jose R. Castillo-Mancilla, MD University of Colorado - Anschutz Medical Campus
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02012621     History of Changes
Other Study ID Numbers: 13-2104
First Submitted: December 4, 2013
First Posted: December 16, 2013
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of Colorado, Denver:
HIV/AIDS
Adherence
Tenofovir
Dried Blood Spots