A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

Genital Herpes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723229
• Other study ID #: 34187-B
• Secondary ID: U19AI031448
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2008
• Last updated: March 6, 2017
• Start date: August 2008
• Est. completion date: September 2011

Study information

• Verified date: March 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• acyclovir
Acyclovir 400 mg PO BID for 28 days

Locations

Country	Name	City	State
United States	University of Washington Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Seronegative and HIV Seropositive Individuals.		9 weeks
Secondary	Quantity of HSV Detected, Median	Median quantity of HSV detected, among swabs with any HSV detected	9 weeks
Secondary	Number of Genital HSV Shedding Episodes	The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs	9 weeks
Secondary	Duration of Genital HSV Shedding Episodes	Median duration of HSV shedding episodes, in hours	9 weeks