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HIV/AIDS | Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy

HIV/AIDS research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

HIV/AIDS

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: December 2013

Completed Date: June 2018

Phase: N/A

Type: Observational

Design:

Primary Outcome: Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with HIV viral suppression at study visit #1 (initial study visit).

Secondary Outcome: Level of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) associated with self-reported adherence at study visit #1 (initial study visit).

Study sponsors, principal investigator, and references

Principal Investigator: Jose R. Castillo-Mancilla, MD

Lead Sponsor: University of Colorado, Denver

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02012621

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