Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 - Full Text View

Sponsor:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00362297

Purpose

The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 15-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.

Condition	Intervention	Phase
Genital Herpes	Drug: acyclovir Drug: valacyclovir	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Acyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

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 high-dose acyclovir as compared to once-daily valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of subclinical shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with high-dose acyclovir as compared to once-daily valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Frequency of lesional shedding from the genital tract as measured by PCR, calculated using a per day shedding rate in participants treated with high-dose acyclovir as compared to once-daily valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Number of herpes recurrences, defined clinically as >=1 successive day on which genital lesions are present, in participants treated with high-dose acyclovir as compared to once-daily valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	82
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: acyclovir 800 mg orally three times daily for 7 weeks
Active Comparator: 2	Drug: valacyclovir 500 mg orally once daily for 7 weeks Other Name: Valtrex

Detailed Description:

Screening Assessment

Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF):

Demographic Data: Date of birth, sex, marital status, education and race
Previous antiviral medication taken
History of sexually transmitted infections and sexual history.

Start of Study Visit (Day 0) and Day 14, 28, 42, 56, 70, 84, 98 and 105 Follow-Up Visits.

Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts.

Crossover Study Visit Prior To Washout Period (Day 49-55)

Participants will not be given study drug or placebo during the 7-day washout period.

Daily Home Viral Sample Collection

Participants will collect swabs from the genital mucosa four times per day and store the samples in PCR media with preprinted labels. Women will swab the cervicovaginal, vulvar and perianal areas, and men will swab the penile and perianal. Every two weeks, they will return the samples to the Virology Research Clinic when they present for additional study drug and assessment.

Final Study Visit (Day 105)

At the final study visit at Day 105 or for premature discontinuation, the investigator will perform the activities at the regular study visits, with the exception of the dispensation of study drug.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older;
HSV-2 seropositive by Western Blot;
not receiving any drugs with known anti-HSV-2 activity for study duration;
history of primary genital herpes infection within past 6 months OR history of 4 or more HSV recurrences per year during the past year OR 4 or more recurrences per year prior to initiation of suppressive antiviral therapy;
able to comply with the study protocol;
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;
women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
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;
planning to remain resident in the area of the study center for the duration of the study participation;
HIV seronegative.

Exclusion Criteria:

hypersensitivity to acyclovir or valacyclovir;
pregnant women;
HIV positive or other immunosuppressed state, including chronic steroid use. Intermittent nasal or topical steroids are acceptable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362297

Locations

United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98122

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator:

Christine Johnston, MD

University of Washington

More Information

No publications provided

Responsible Party:	Christine Johnston, MD, MPH, University of Washington
ClinicalTrials.gov Identifier:	NCT00362297 History of Changes
Other Study ID Numbers:	30520-D - Phase 1
Study First Received:	August 8, 2006
Last Updated:	April 29, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female

Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Valacyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012