A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genital Herpes
Intervention: acyclovir (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Christine Johnston, MD, MPH, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frequency of HSV-2 total shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with suppressive acyclovir as compared to no medication in HIV sero-negative AND HIV seropositive individuals.
Secondary outcome: Frequency of subclinical shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with with suppressive acyclovir as compared to no medication.Frequency of lesional shedding from the genital tract as measured by PCR, calculated using a per day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. Number of herpes recurrences, defined clinically as >=1 successive day on which genital lesions are present, in participants treated with with suppressive acyclovir as compared to no medication.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Washington Virology Research Clinic, Seattle, Washington 98122, United States
Additional Information
Starting date: August 2008
Last updated: July 20, 2010
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