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NCT01448616 · ClinicalTrials.gov registry record · Phase 4
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
A Phase 4 study of Herpes Simplex Type II, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT01448616 is a Phase 4 study of Herpes Simplex Type II that has completed, run by University of Washington. The registered enrollment target is 73 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01448616, a Phase 4 study of Herpes Simplex Type II, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir will reduce genital HSV shedding compared to placebo.
Conditions Studied
Interventions
- DRUG TDF
- DRUG Placebo Tablets
- DRUG Placebo Vaginal Gel
- DRUG Vaginal TFV Gel
Study Locations (1)
Washington
- University of Washington Virology Research Clinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01448616
The ClinicalTrials.gov registry entry for NCT01448616 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Herpes Simplex Type II appearing as the primary indexed condition, and to 4 interventions - of which TDF is the first listed.
NCT01448616 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT01448616 about?
NCT01448616 is a clinical study titled "Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding". The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) sero...
What is the current status of trial NCT01448616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 73 participants. The study started on 2012-02. Estimated completion is 2015-06.
What conditions does trial NCT01448616 study?
This clinical trial studies the following conditions: Herpes Simplex Type II.
What interventions are being tested in trial NCT01448616?
The interventions under investigation include: TDF (DRUG), Placebo Tablets (DRUG), Placebo Vaginal Gel (DRUG), Vaginal TFV Gel (DRUG).
Who is sponsoring clinical trial NCT01448616?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01448616 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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