Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04302896 · ClinicalTrials.gov registry record · Early Phase 1
Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs
A Early Phase 1 study of HIV and Medication Adherence, sponsored by Rhonda Brand.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04302896: Completed Early Phase 1 study of HIV and Medication Adherence, sponsored by Rhonda Brand.
NCT04302896 is a Early Phase 1 study of HIV and Medication Adherence that has completed, run by Rhonda Brand. The registered enrollment target is 30 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04302896, a Early Phase 1 study of HIV and Medication Adherence, has completed, sponsored by Rhonda Brand.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, open label study to identify adherence levels of commonly prescribed FDA-approved antiretroviral agents by tracking the decline of drug concentrations in plasma, urine and saliva following abrupt drug cessation in HIV-negative adults. Results from this study may provide support for development of a point of care urine testing device to monitor drug adherence.
Primary Outcome
Cmax of dolutegravir, emtricitabine, lamivudine, tenofovir disoproxil fumarate, tenofovir alafenamide, and metabolites in plasma, whole blood (dried spot), saliva, and urine as measured by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Conditions Studied
Interventions
- DRUG dolutegravir oral tablet 50mg
- DRUG emtricitabine/tenofovir alafenamide oral tablet 200mg/25mg
- DRUG tenofovir disoproxil fumarate oral tablet 300mg
- DRUG lamivudine oral tablet 300mg
Study Locations (1)
Pennsylvania
- HIV/AIDS Clinical Research Unit / University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2021-09-30 |
| Phase | Early Phase 1 |
What the finished NCT04302896 record still lists
NCT04302896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 4 interventions - of which dolutegravir oral tablet 50mg is the first listed.
NCT04302896 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04302896 about?
NCT04302896 is a clinical study titled "Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs". This is a single-center, open label study to identify adherence levels of commonly prescribed FDA-approved antiretroviral agents by tracking the decline of drug concentrations in plasma, urine and saliva following abrupt drug cessation in HIV-negative adults. Results from this study may provide supp...
What is the current status of trial NCT04302896?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2020-08-31. Estimated completion is 2021-09-30.
What conditions does trial NCT04302896 study?
This clinical trial studies the following conditions: HIV, Medication Adherence.
What interventions are being tested in trial NCT04302896?
The interventions under investigation include: dolutegravir oral tablet 50mg (DRUG), emtricitabine/tenofovir alafenamide oral tablet 200mg/25mg (DRUG), tenofovir disoproxil fumarate oral tablet 300mg (DRUG), lamivudine oral tablet 300mg (DRUG).
Who is sponsoring clinical trial NCT04302896?
This trial is sponsored by Rhonda Brand, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04302896 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04302896's enrollment target sits among peer trials
30 264th of 303 higher than 31 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
RECRUITING · Early Phase 1
-
Transitional Housing and HIV Health
RECRUITING
-
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
RECRUITING · Phase 1
-
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
RECRUITING
-
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
RECRUITING · Phase 2
-
Text Education About Cardiovascular Health and HIV (TEACH-HIV)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI