View Clinical Trial (Medical Research Study)
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation - NCT00723229-98122(Clinical Trial 233686)
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| City: |
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Seattle |
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State:
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WA |
| Zip Code: |
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98122 |
| Conditions: |
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Genital Herpes |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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July 21, 2010 |
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