Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04820933 · ClinicalTrials.gov registry record · Early Phase 1
Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV
A Early Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT04820933: Completed Early Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT04820933 is a Early Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 26 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04820933, a Early Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This research application will explore the impact of the Non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine in the setting of established Nucleoside reverse transcriptase inhibitors (NRTIs) backbone \[Tenofovir alafenamide (TAF) / Emtricitabine (FTC) as a possible therapeutic strategy to minimize the detrimental impact of ART-related toxicities on metabolism and instigators of atherosclerosis. Given the possible favorable role of NNRTI in pathogenesis of HIV-related dyslipidemia and cardiovascular disease (CVD), this research will provide mechanistic insights into HIV pathogenesis and safety data regarding doravirine (DOR). These data may promote DOR as a robust "HDL friendly" and "metabolism friendly", therapeutic agent that may attenuate morbidity in chronic treated HIV infection. Towards this aim, the investigators will study DOR-related effects on HDL (HDL-C levels and function) and ex vivo assays that determine key molecular determinants of atherogenesis.
Primary Outcome
Primary outcome (instigator of atherosclerosis). This is a measure of the lipid peroxide content of HDL per specific amount of HDL relative to the measure of this value in a pooled healthy control (normalized ratio; no units).
Interventions
- DRUG Doravirine 100 Mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2025-12-01 |
| Phase | Early Phase 1 |
What the finished NCT04820933 record still lists
NCT04820933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 1 intervention - of which Doravirine 100 Mg is the first listed.
NCT04820933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04820933 about?
NCT04820933 is a clinical study titled "Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV". This research application will explore the impact of the Non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine in the setting of established Nucleoside reverse transcriptase inhibitors (NRTIs) backbone \[Tenofovir alafenamide (TAF) / Emtricitabine (FTC) as a possible therapeutic strategy...
What is the current status of trial NCT04820933?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2024-03-01. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT04820933?
The interventions under investigation include: Doravirine 100 Mg (DRUG).
Who is sponsoring clinical trial NCT04820933?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04820933's enrollment target sits among peer trials
26 977th of 2000 higher than 1,002 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
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
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
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