Clinical Trials Directory

Trials / Completed

CompletedNCT00723229

A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
48 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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 propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count\>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.

Conditions

Interventions

TypeNameDescription
DRUGacyclovirAcyclovir 400 mg PO BID for 28 days

Timeline

Start date
2008-08-01
Primary completion
2010-07-01
Completion
2011-09-01
First posted
2008-07-28
Last updated
2017-03-09
Results posted
2017-03-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00723229. Inclusion in this directory is not an endorsement.