Genital Herpes Clinical Trial
Official title:
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
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.
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.
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