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Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
NCT04006704 · View on ClinicalTrials.gov ↗
Study Summary
The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).
Conditions Studied
Interventions
- DRUG D/C/F/TAF FDC placebo
Study Locations (8)
Other
- Hosp. Sant Joan de Deu — Esplugues de Llobregat
- Hosp. Gral. Univ. Gregorio Marañon — Madrid
- Hosp. Univ. 12 de Octubre — Madrid
- Hosp. Univ. La Paz — Madrid
Arizona
- Phoenix Children's Hospital — Phoenix
Georgia
- Emory University — Atlanta
Tennessee
- St Jude Children's Research Hospital — Memphis
Texas
- University of Texas Health Science Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04006704
The ClinicalTrials.gov registry entry for NCT04006704 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Pharmaceutica N.V., Belgium, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV-1 appearing as the primary indexed condition, and to 1 intervention — of which D/C/F/TAF FDC placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04006704 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Other, Arizona, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04006704 about?
NCT04006704 is a clinical study titled "Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets". The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).
What is the current status of trial NCT04006704?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-10-10. Estimated completion is 2020-03-06.
What conditions does trial NCT04006704 study?
This clinical trial studies the following conditions: HIV-1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04006704?
The interventions under investigation include: D/C/F/TAF FDC placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04006704?
This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04006704 being conducted?
This trial has 8 study locations across Arizona, Georgia, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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