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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02012621
First received: December 4, 2013
Last updated: June 10, 2014
Last verified: June 2014

December 4, 2013
June 10, 2014
December 2013
June 2018   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02012621 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy
Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole Blood

Non-Probability Sample

HIV-infected individuals who are taking tenofovir.

HIV/AIDS
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
June 2018
June 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Not taking tenofovir.
  • Refusal to participate.
Both
18 Years to 89 Years
No
Contact: Jose R. Castillo-Mancilla, MD 303-724-4934 jose.castillo-mancilla@ucdenver.edu
United States
 
NCT02012621
13-2104
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Jose R. Castillo-Mancilla, MD University of Colorado-Anschutz Medical Campus
University of Colorado, Denver
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP