Status:
COMPLETED
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Genital Herpes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 suppressi...
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 suppressi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00723229
Start Date
August 1 2008
End Date
September 1 2011
Last Update
March 9 2017
Active Locations (1)
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1
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98122