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NCT00799864 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

A Phase 2 study, sponsored by Janssen Sciences Ireland UC.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target

NCT00799864 is a Phase 2 study that has completed, run by Janssen Sciences Ireland UC. The registered enrollment target is 54 participants.

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The verdict

NCT00799864, a Phase 2 study, has completed, sponsored by Janssen Sciences Ireland UC.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\], or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (\>=) 6 to less than (\<) 18 years.

Interventions

  • DRUG Zidovudine
  • DRUG Abacavir
  • DRUG Lamivudine
  • DRUG Tenofovir disoproxil fumarate
  • DRUG Rilpivirine

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2011-01
Est. Completion 2022-08
Phase Phase 2

Sponsor

Janssen Sciences Ireland UC

7 total trials

What the Registry Record Tells You About NCT00799864

The ClinicalTrials.gov registry entry for NCT00799864 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Sciences Ireland UC, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Zidovudine is the first listed.

NCT00799864 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00799864 about?

NCT00799864 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years". The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t...

What is the current status of trial NCT00799864?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2011-01. Estimated completion is 2022-08.

What interventions are being tested in trial NCT00799864?

The interventions under investigation include: Zidovudine (DRUG), Abacavir (DRUG), Lamivudine (DRUG), Tenofovir disoproxil fumarate (DRUG), Rilpivirine (DRUG).

Who is sponsoring clinical trial NCT00799864?

This trial is sponsored by Janssen Sciences Ireland UC, which has 7 total clinical trials registered on ClinicalTrials.gov.

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

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.