Antiretroviral Adherence and Drug-level Monitoring

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996094
• Other study ID #: 3578141P111242020012800013
• Status: Recruiting
• Start date: October 16, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: University of Groningen
• Contact: Zamrotul Izzah
• Phone: 6285655191257
• Email: zamrotulizzah[@]ff.unair.ac.id
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• AIDS
• Antiretroviral Therapy, Highly Active
• HIV Infections

Locations

Country	Name	City	State
Indonesia	Universitas Airlangga Hospital	Surabaya	East Java

Sponsors (2)

Lead Sponsor	Collaborator
Zamrotul Izzah	Universitas Airlangga

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to antiretroviral therapy	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	Tenofovir concentrations	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)
Secondary	Viral load	The viral load test will measure the number of HIV copies in plasma (in copies/ml).	Baseline and 6 months
Secondary	CD4 cell count	The cluster of differentiation 4 (CD4) cell count test will quantify CD4 cells in plasma (in cells/mm^3).	Baseline and 6 months