HIV Infections Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Universitas Airlangga Hospital | Surabaya | East Java |
Lead Sponsor | Collaborator |
---|---|
Zamrotul Izzah | Universitas Airlangga |
Indonesia,
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 |
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