Antiretroviral Adherence and Drug-level Monitoring

August 17, 2023 updated by: Zamrotul Izzah

Adherence and Pharmacokinetics Measures in People Living With HIV Receiving Tenofovir Disoproxil Fumarate-based Regimens in Indonesia

This observational study aims to investigate medication adherence and drug-level monitoring of antiretroviral agents in a cohort of people living with HIV in Indonesia. The study is conducted in outpatients receiving tenofovir-based regimens in a university medical centre.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Optimal adherence is critical to achieve and sustain viral suppression. Currently, there is no gold standard measure of antiretroviral adherence and exposure in clinical practice. Recent studies have evaluated the use of emerging biological matrices such as dried blood spots, urine, and saliva as means of objective adherence measures. For drug-level monitoring, tenofovir is selected as a drug of interest and thus only people receiving tenofovir disoproxil fumarate-based regimens will be monitored. Some studies have reported that higher plasma trough concentrations of tenofovir were associated with renal toxicity. Therefore, this project aims to measure level of adherence and tenofovir concentrations in plasma and emerging matrices among people living with HIV in Indonesia. Primary outcome is adherence to ART that will be measured using multi methods, including self-report questionnaire, pill counting, electronic monitoring, and drug-level testing. Secondary outcomes include tenofovir concentrations in plasma, urine, saliva, and dried blood spots and clinical outcomes (viral load and CD4 count). Assays for measuring tenofovir concentrations will be developed using high-performance liquid chromatography-tandem mass spectrometry. Concentrations derived from dried blood spots, saliva, and urine will be compared to plasma concentrations. Pharmacokinetic models will be used to interpret drug-level monitoring. The association of adherence measures as well as drug concentrations and clinical outcomes will be examined.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All people living with HIV receiving antiretroviral therapy who regularly visit the HIV clinic at a university medical centre in Surabaya, Indonesia, during study period.

Description

Inclusion Criteria:

  • Adults with HIV who have been receiving antiretroviral therapy containing tenofovir-based regimens for at least six months

Exclusion Criteria:

  • Pregnant and breastfeeding women, people with kidney failure, undergoing hemodialysis or peritoneal dialysis, uncontrolled diabetes, uncontrolled hypertension, and hypersensitivity to tenofovir

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to antiretroviral therapy
Time Frame: Baseline and 6 months
Adherence to antiretroviral therapy (ART) will be assessed using a validated Bahasa Indonesia version of self-reported adherence questionnaire. The questionnaire will recall ART use in the past week, past month, and past three months. The percentages of adherence will be calculated by the formula: (total number of dosage units prescribed - total number of times reported) / (total number of dosage units prescribed) × 100. The adherence scales range from 0 to 100% with higher scales denote higher adherence. Being highly adherent to ART is defined by having an adherence higher than 80%.
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tenofovir concentrations
Time Frame: Baseline (pre-dose, 1, and 4 h post-dose) and 6 months (random 3 - 16 h post-dose)
Concentrations of tenofovir in plasma, saliva, urine, and dried blood spots
Baseline (pre-dose, 1, and 4 h post-dose) and 6 months (random 3 - 16 h post-dose)
Viral load
Time Frame: Baseline and 6 months
The viral load test will measure the number of HIV copies in plasma (in copies/ml).
Baseline and 6 months
CD4 cell count
Time Frame: Baseline and 6 months
The cluster of differentiation 4 (CD4) cell count test will quantify CD4 cells in plasma (in cells/mm^3).
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zamrotul Izzah

Collaborators

Universitas Airlangga

Investigators

  • Principal Investigator: Zamrotul Izzah, Universitas Airlangga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3578141P111242020012800013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data will be available for analysing and reporting purposes and for other parties upon formal request to the principal investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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