Monitoring medication adherence and drug levels in HIV patients
Adherence and Pharmacokinetics Measures in People Living With HIV Receiving Tenofovir Disoproxil Fumarate-based Regimens in Indonesia
This study is trying to see how well people with HIV in Indonesia stick to their medication and how that affects the levels of the drug in their body and their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Groningen Academic / other |
| Locations | 1 site (Surabaya, East Java) |
| Trial ID | NCT05996094 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how well people living with HIV in Indonesia adhere to their antiretroviral therapy, specifically focusing on tenofovir-based regimens. It employs multiple methods to measure adherence, including self-reports, pill counting, and electronic monitoring, alongside drug-level testing in various biological matrices. The study aims to correlate adherence levels with tenofovir concentrations in plasma, urine, saliva, and dried blood spots, while also assessing clinical outcomes like viral load and CD4 count. By developing assays for measuring drug concentrations, the research seeks to enhance understanding of adherence and its impact on treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults living with HIV who have been on tenofovir-based antiretroviral therapy for at least six months.
Not a fit: Patients who are pregnant, breastfeeding, have kidney failure, or uncontrolled chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for monitoring and enhancing medication adherence in HIV patients, ultimately improving health outcomes.
How similar studies have performed: Other studies have shown success in using biological matrices for adherence monitoring, making this approach promising yet still evolving.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Surabaya, East Java
- Universitas Airlangga Hospital — Surabaya, East Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Zamrotul Izzah — Universitas Airlangga
- Study coordinator: Zamrotul Izzah
- Email: zamrotulizzah@ff.unair.ac.id
- Phone: 6285655191257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.