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NCT00905489 · ClinicalTrials.gov registry record · Phase 1
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
A Phase 1 study of HIV Infections, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 10
- Study locations
NCT00905489 is a Phase 1 study of HIV Infections that has completed, run by Boehringer Ingelheim. The registered enrollment target is 85 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower). The trial reports 10 study locations across 3 states.
The verdict
NCT00905489, a Phase 1 study of HIV Infections, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from \>=3 to \<18 years of age. This phase I trial is an open-label, multiple dose, non-randomized and cross-over study. Patients who have completed the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program. During this OEP, nevirapine XR safety and efficacy information will be collected.
Conditions Studied
Interventions
- DRUG Nevirapine Immediate Release (IR)
- DRUG Nevirapine Extended Release (XR)
Study Locations (10)
Other
- 1100.1518.2605 Boehringer Ingelheim Investigational Site - Francistown
- 1100.1518.2601 Boehringer Ingelheim Investigational Site - Gaborone
- 1100.1518.2603 Boehringer Ingelheim Investigational Site - Gaborone
- 1100.1518.4902 Boehringer Ingelheim Investigational Site - Berlin
- 1100.1518.4901 Boehringer Ingelheim Investigational Site - Frankfurt am Main
- 1100.1518.4903 Boehringer Ingelheim Investigational Site - München
- 1100.1518.2702 Boehringer Ingelheim Investigational Site - Cape Town
- 1100.1518.2703 Boehringer Ingelheim Investigational Site - Parow Valley
District of Columbia
- 1100.1518.0001 Boehringer Ingelheim Investigational Site - Washington D.C.
Pennsylvania
- 1100.1518.0002 Boehringer Ingelheim Investigational Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00905489
The ClinicalTrials.gov registry entry for NCT00905489 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Nevirapine Immediate Release (IR) is the first listed.
NCT00905489 reports 10 study locations spanning 3 distinct geographic areas - top geographies include Other, District of Columbia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00905489 about?
NCT00905489 is a clinical study titled "A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.". The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from \>=3 to \<18 years of age. This phase I trial is an open-label, multiple dose, non-randomized and cross-over study. Patients who have completed the last visit of the ...
What is the current status of trial NCT00905489?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2009-06. Estimated completion is 2012-09.
What conditions does trial NCT00905489 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00905489?
The interventions under investigation include: Nevirapine Immediate Release (IR) (DRUG), Nevirapine Extended Release (XR) (DRUG).
Who is sponsoring clinical trial NCT00905489?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00905489 being conducted?
This trial has 10 study locations across District of Columbia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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