Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of HIV Infections, sponsored by Boehringer Ingelheim.
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. According to ClinicalTrials.gov, the official US trial registry.
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of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program.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.
Primary Outcome
Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22. The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation.
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 |
What the finished NCT00905489 record still lists
NCT00905489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower).
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 lists 10 locations in 3 states (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.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00905489's enrollment target sits among peer trials
85 294th of 542 higher than 248 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00842283 · 85 participants
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target
- NCT02133196 · 85 participants · Phase 2
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
- NCT03823144 · 85 participants · NA
Intravital Microscopy in Human Solid Tumors
- NCT03875638 · 85 participants · Phase 2
Treating Hyperexcitability in AD With Levetiracetam
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia