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NCT01300988 · ClinicalTrials.gov registry record · Phase 1
Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals. 375 mg Dose
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01300988: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT01300988 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300988, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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. 18 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 to receive 375 mg of aprepitant (Emend®) or placebo.
Interventions
- DRUG Aprepitant
- DRUG Aprepitant placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01300988
The ClinicalTrials.gov registry entry for NCT01300988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aprepitant is the first listed.
NCT01300988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01300988 about?
NCT01300988 is a clinical study titled "Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals. 375 mg Dose". 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 NCT01300988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-12. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01300988?
The interventions under investigation include: Aprepitant (DRUG), Aprepitant placebo (DRUG).
Who is sponsoring clinical trial NCT01300988?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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