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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-01 |
| Est. Completion | 2022-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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