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NCT03332095 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
55
Enrollment target

NCT03332095 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 55 participants.

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The verdict

NCT03332095, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
55 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the pharmacokinetics, safety, and tolerability of doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.

Interventions

  • DRUG Doravirine (DOR)
  • DRUG Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF)
  • DRUG Antiretroviral (ARV) medications

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2018-07-02
Est. Completion 2022-05-25
Phase Phase 1

What the Registry Record Tells You About NCT03332095

The ClinicalTrials.gov registry entry for NCT03332095 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Doravirine (DOR) is the first listed.

NCT03332095 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03332095 about?

NCT03332095 is a clinical study titled "Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents". The purpose of this study was to evaluate the pharmacokinetics, safety, and tolerability of doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.

What is the current status of trial NCT03332095?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2018-07-02. Estimated completion is 2022-05-25.

What interventions are being tested in trial NCT03332095?

The interventions under investigation include: Doravirine (DOR) (DRUG), Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) (DRUG), Antiretroviral (ARV) medications (DRUG).

Who is sponsoring clinical trial NCT03332095?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.