Expired Study
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Seattle, Washington 98122


Purpose:

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 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 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.


Criteria:

Inclusion Criteria: COHORT 1: HIV seronegative 1. Older than 18 years; 2. HSV-2 seropositive by Western Blot; 3. not receiving any drugs with known anti-HSV-2 activity for study duration; 4. 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; 5. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit; 6. 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; 7. planning to remain resident in the area of the study center for the duration of the study participation; 8. HIV seronegative COHORT 2: HIV seropositive 1. Older than18 years; 2. HSV-2 seropositive by Western Blot; 3. not receiving any drugs with known anti-HSV-2 activity for study duration; 4. 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; 5. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit; 6. 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; 7. planning to remain resident in the area of the study center for the duration of the study participation; 8. HIV seropositive 9. CD4 count over 250 cell/mm3 10. Not taking antiretroviral therapy Exclusion Criteria: For both cohorts: 1. hypersensitivity to acyclovir or valacyclovir; 2. pregnant women; 3. Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs. For cohort 2: 1. CD4 count<250 cell/mm3 2. Taking antiretroviral therapy at the time of study entry


NCT ID:

NCT00723229


Primary Contact:

Principal Investigator
Christine Johnston, MD, MPH
University of Washington


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98122
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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