Valaciclovir to Prevent Transmission of Herpes Simplex Virus

NCT00001649 | Completed Phase 3

• 2 other identifiers: 97016897-I-0168
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of the drug valaciclovir in preventing transmission of genital herpes from an infected to an uninfected sexual partner. Genital herpes is caused by the herpes simplex virus 2 (HSV-2), or, infrequently herpes simplex virus 1 (HSV-1). Valaciclovir prevents the herpes virus from multiplying and may also reduce its transmission between partners. Couples 18 years of age and older in which one partner is infected with HSV-2 (source partner) and the other is not (susceptible partner), may be eligible for this study. Candidates will be screened with blood tests for routine laboratory studies and to verify the presence or absence of HSV-2 or HSV-1 infection. Participants will give a medical history, undergo a physical examination, including genital examination, and receive counseling on safer sex practices and how to recognize signs and symptoms of a possible first episode of genital herpes. Source partners will also be counseled on transmission of genital herpes, and susceptible partners will be interviewed about their sexual history and practices. The source partner will be randomly assigned to take either a 500-mg tablet of valaciclovir or placebo (a pill with no active ingredient) daily for 8 months. All participants will be given diary cards to complete for a month-the source partner will record any drug side effects and the susceptible partner will record any signs or symptoms of possible HSV infection. Participants will be seen in the clinic once a month for 8 months. At these visits, source partners will 1) return unused study medication and the completed diary card; 2) discuss any adverse drug side effects experienced in the last month; 3) review medications other than the study drug taken in the last month; 4) undergo counseling on safer sex practices, transmission of genital herpes, and recognizing signs and symptoms of a first episode of genital herpes; and 5) review symptoms and recurrences of genital herpes experienced during the last month. During the final visit, they will also provide a blood sample for routine testing and possible use in future studies. Susceptible partners will 1) have a blood sample drawn for HSV testing; 2) undergo safer sex counseling; 3) review any symptoms experienced over the last month; 4) be interviewed about sexual exposure and practices; and 5) return the completed diary card. Source partners who have a recurrence of genital HSV while on the study will be asked to have their lesions cultured and will be offered open-label valaciclovir treatment. Susceptible partners who contract genital herpes from the source partner during the study will have a genital examination to verify a fist episode of genital herpes and will receive 10 days of open-label treatment with valaciclovir. Cultures will be taken from the mouth and genitals, current medical conditions will be reviewed, blood samples will be drawn on treatment days 1 and 10, and treatment side effects will be reviewed on days 5 and 10. At the end of the study, infected partners will be offered a 12-month course of valaciclovir, one 500-mg tablet daily. Participants will be followed in the clinic once every 3 months to provide blood samples, return unused study medication and the diary card, discuss any drug side effects, review medications taken besides the study drug, and review symptoms or recurrences of genital herpes. All participants will be asked to complete a questionnaire for gathering information about people with genital herpes and people at risk for the infection.

Conditions

Herpes Simplex

Keywords

Clinical Trial; Sexual Transmitted Disease; Phase III; HSV; Valtrex; Valaciclovir; HS2A/B3009; Herpes Simplex Virus Transmission; Heterosexual Couples

Interventions

Valaciclovir DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• General good health as determined by current medical status and laboratory tests.
• Active heterosexual relationship with susceptible partner.
• Presence of HSV-2 serum antibody as determined by Western blot analysis.
• History of symptomatic recurrent genital herpes.
• Off HSV suppressive therapy upon entering study.
• In the opinion of the investigator, able to comply with protocol requirements.
• In the investigator's opinion, subjects must be candidates for receiving suppressive therapy for management of their disease.
• Written informed consent.

You may not qualify if:

• Patients who are known or suspected to be immunocompromised (e.g., patients receiving immunosuppressive therapy, patients with malignancy or seropositive for HIV).
• Subjects with a history of 10 or more HSV recurrences per year.
• Impaired renal function as defined by serum creatinine greater than 1.5 mg/dL or estimated creatinine clearance less than 30 ml/min.
• Impaired hepatic function defined as an alanine transaminase (ALT) level greater than 3 times the normal upper limit.
• Known resistance to aciclovir, famciclovir, or ganciclovir.
• Known hypersensitivity to aciclovir, valaciclovir, famciclovir, or ganciclovir.
• Malabsorption syndrome or other gastrointestinal dysfunction that might impair drug dynamics.
• Subjects known to be lactose intolerant.
• Women contemplating pregnancy within the duration of study drug dosing for this study.
• Women of child bearing potential not using an effective method of contraception.
• Positive pregnancy test (or pregnant females or nursing mothers).
• years of age or older.
• General good health as determined by current medical status.
• Active monogamous, heterosexual relationship with source partner.
• Absence of HSV-2 serum antibody as determined by Western blot analysis.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Wagner HU, Van Dyck E, Roggen E, Nunn AJ, Kamali A, Schmid DS, Dobbins JG, Mulder DW. Seroprevalence and incidence of sexually transmitted diseases in a rural Ugandan population. Int J STD AIDS. 1994 Sep-Oct;5(5):332-7. doi: 10.1177/095646249400500509.

  PMID: 7819350 BACKGROUND

• Greenblatt RM, Lukehart SA, Plummer FA, Quinn TC, Critchlow CW, Ashley RL, D'Costa LJ, Ndinya-Achola JO, Corey L, Ronald AR, et al. Genital ulceration as a risk factor for human immunodeficiency virus infection. AIDS. 1988 Feb;2(1):47-50. doi: 10.1097/00002030-198802000-00008.

  PMID: 3128996 BACKGROUND

• Mertz GJ, Benedetti J, Ashley R, Selke SA, Corey L. Risk factors for the sexual transmission of genital herpes. Ann Intern Med. 1992 Feb 1;116(3):197-202. doi: 10.7326/0003-4819-116-3-197.

  PMID: 1309413 BACKGROUND

MeSH Terms

Conditions

Herpes Simplex; Sexually Transmitted Diseases

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: August 1, 1997
• Study Completion: August 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-08

Locations

US (1)