N/A
Completed N=807
Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy
Source: ClinicalTrials.gov NCT02012621 ↗Enrolled (actual)
807
Serious AEs
—
Results posted
Nov 2019
Primary outcomePrimary: Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at All Study Visits — 73.5 Adjusted odds ratio (aOR) — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at All Study Visits |
73.5 | <0.0001 sig |
| PRIMARY Adjusted Odds Ratio of Three-month Self-reported Adeherence Associated With Odds of HIV Viral Suppression at All Study Visits |
8.5 | 0.0012 sig |
| PRIMARY Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at Next Study Visit |
4.7 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- HIV-infected individual.
- 18 years and older.
- Taking tenofovir.
- Blood drawn during regular clinic visit.
Exclusion Criteria
- Refusal to participate.
- Pregnancy.
- Inability to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT02012621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.