At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 48 enrolled
Drug / intervention
acyclovirdrug
Likely dose
acyclovir 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of Acyclovir on Rapidly Cleared Herpes Simplex Virus Type 2 Genital Reactivation Episodes in Herpes Simplex Virus-2 Seropositive Adults
In Brief
A Phase 4 clinical trial evaluating acyclovir for Genital Herpes. Completed, enrolled 48 participants across 1 site.
Detailed Summary
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenital Herpes
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartAug 2008
Primary CompletionJul 2010
Study CompletionSep 2011
TodayJul 2026
First PostedJul 28, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.9 years ago
Interventions
acyclovirdrug
Acyclovir 400 mg PO BID for 28 days