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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: Completed Phase 4 study of Herpes Simplex Type II, sponsored by University of Washington.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and
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 |
What the finished NCT01448616 record still lists
NCT01448616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01448616's enrollment target sits among peer trials
73 1033rd of 2000 higher than 967 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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