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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

Page last updated: August 23, 2015

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