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

NCT01346475 | Completed Phase 4 Results

• 1 other identifier: 30520-D - Phase 2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications. The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 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 11-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 once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 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.

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

• 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 Valacyclovir as Compared to Once-daily Valacyclovir.

  11 weeks

Secondary Outcomes (3)

• Quantity of HSV Detected, Median

  11 weeks

• Number of Genital HSV Shedding Episodes

  11 weeks

• Duration of Genital HSV Shedding Episodes

  11 weeks

Study Arms (2)

valacyclovir

ACTIVE COMPARATOR

Drug: Valacyclovir

high dose valacyclovir

EXPERIMENTAL

Drug: valacyclovir

Interventions

Valacyclovir DRUG

1000 mg orally three times daily for 5 weeks

high dose valacyclovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; or shedding HSV-2 from genital mucosa on \>25% of days in shedding session performed at the VRC within the last 2 years.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4.

  PMID: 22225814 DERIVED

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This trial was performed at a single site and enrolled healthy, mostly white adults with frequent genital herpes outbreaks. Whether these finding are generalizable to other populations is unknown.

Results Point of Contact

• Title: Dr. Christine Johnston
• Organization: University of Washington

cjohnsto@u.washington.edu

206-520-4340

Study Officials

• Christine Johnston, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2011
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-03

Locations

US (1)