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NCT00428519 · ClinicalTrials.gov registry record · Phase 1
Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals
A Phase 1 study of HIV Infections, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00428519: Completed Phase 1 study of HIV Infections, sponsored by University of Pennsylvania.
NCT00428519 is a Phase 1 study of HIV Infections that has completed, run by University of Pennsylvania. The registered enrollment target is 30 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00428519, a Phase 1 study of HIV Infections, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential antiviral effect this could alter disease progression in patients with HIV infection. The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral activity in HIV infected individuals. This is randomized, placebo controlled, double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy. 27 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell counts ≥ 350 cells/mm3. Subjects will be randomized 1:1:1 to receive two different doses of aprepitant (Emend®) or placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aprepitant
Study Locations (1)
Pennsylvania
- Clinical Trials Unit. University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00428519
The ClinicalTrials.gov registry entry for NCT00428519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 (93% lower). The listed sponsor is University of Pennsylvania, which has 1,423 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 Placebo is the first listed.
NCT00428519 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00428519 about?
NCT00428519 is a clinical study titled "Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals". The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those observed in patients heterozygous...
What is the current status of trial NCT00428519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2007-01. Estimated completion is 2009-12.
What conditions does trial NCT00428519 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00428519?
The interventions under investigation include: Placebo (DRUG), Aprepitant (DRUG).
Who is sponsoring clinical trial NCT00428519?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00428519 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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