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NCT01749566 · ClinicalTrials.gov registry record · Phase 1
Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women
A Phase 1 study of HIV, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01749566: Completed Phase 1 study of HIV, sponsored by Emory University.
NCT01749566 is a Phase 1 study of HIV that has completed, run by Emory University. The registered enrollment target is 31 participants, below the 440-participant average among 303 other HIV 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
NCT01749566, a Phase 1 study of HIV, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are used by a person before they are exposed to HIV in order to decrease his or her chance of getting infected. In this study, we will investigate a new PrEP strategy in women using a drug called maraviroc, a medicine used in the treatment of HIV infection called a CCR5 antagonist. We hypothesize that maraviroc could be a particularly good drug for PrEP because it achieves high concentrations in the genital tract in women and decreases the number of HIV-susceptible cells in the genital tract, and thus could potentially be dosed in more favorable ways than the current PrEP drugs. In order to further evaluate this PrEP strategy, we plan to measure the amount of maraviroc in the blood and genital tract of HIV-negative healthy female volunteers before, during, and after they are given maraviroc dosed either in the standard (twice a day) or reduced (once a day) dose for 7 days compared with women who are not given maraviroc. We will also study immune cells from the blood and genital tract from these women to see if maravoric has an effect on these cells that would prevent them from becoming infected with HIV.
Conditions Studied
Interventions
- DRUG maraviroc
Study Locations (1)
Georgia
- Grady Infectious Diseases Program - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01749566 record still lists
NCT01749566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which maraviroc is the first listed.
NCT01749566 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01749566 about?
NCT01749566 is a clinical study titled "Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women". Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are used by a person before they are exposed to HIV in order to decrease his or her chance of getting infected. In this study, we will investigate a new PrEP strategy in women using a drug called maraviroc, a medici...
What is the current status of trial NCT01749566?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2012-12. Estimated completion is 2015-05.
What conditions does trial NCT01749566 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01749566?
The interventions under investigation include: maraviroc (DRUG).
Who is sponsoring clinical trial NCT01749566?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01749566 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01749566's enrollment target sits among peer trials
31 263rd of 303 higher than 41 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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.
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