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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: Completed Phase 2 study, sponsored by Janssen Sciences Ireland UC.
NCT00799864 is a Phase 2 study that has completed, run by Janssen Sciences Ireland UC. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax,ss was the maximum observed plasma concentration of rilpivirine at steady state (steady state starting from Day 14).
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 |
What the finished NCT00799864 record still lists
NCT00799864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which Zidovudine is the first listed.
NCT00799864 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00799864's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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