A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Completed · Phase 4
Conditions studied: Genital Herpes
In brief
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.
Key facts
- Study ID
- NCT00723229
- Run by
- University of Washington
- People needed
- 48
- Starts
- 2008-08-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2017-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- COHORT 1: HIV seronegative
- Older than 18 years;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seronegative
- COHORT 2: HIV seropositive
- Older than18 years;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seropositive
- CD4 count over 250 cell/mm3
- Not taking antiretroviral therapy
You may not qualify if…
- For both cohorts:
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.
- For cohort 2:
- CD4 count<250 cell/mm3
- Taking antiretroviral therapy at the time of study entry
Where it is running
- University of Washington Virology Research Clinic — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.