Trial record 4 of 31 for:    " December 04, 2013":" January 03, 2014"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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) ] [ 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 ]

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) ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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:

  • Not taking tenofovir.
  • Refusal to participate.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02012621     History of Changes
Other Study ID Numbers: 13-2104
Study First Received: December 4, 2013
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014