Nctid:
NCT00001649
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D006561", "term"=>"Herpes Simplex"}], "ancestors"=>[{"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D017193", "term"=>"Skin Diseases, Viral"}, {"id"=>"D012874", "term"=>"Skin Diseases, Infectious"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M9639", "name"=>"Herpes Simplex", "asFound"=>"Herpes Simplex", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19501", "name"=>"Skin Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M15677", "name"=>"Skin Diseases, Infectious", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077483", "term"=>"Valacyclovir"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M1809", "name"=>"Valacyclovir", "asFound"=>"SpO", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>180}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2003-08", "completionDateStruct"=>{"date"=>"2003-08"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Clinical Trial", "Sexual Transmitted Disease", "Phase III", "HSV", "Valtrex", "Valaciclovir", "HS2A/B3009", "Herpes Simplex Virus Transmission", "Heterosexual Couples"], "conditions"=>["Herpes Simplex"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7819350", "type"=>"BACKGROUND", "citation"=>"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"=>"3128996", "type"=>"BACKGROUND", "citation"=>"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"=>"1309413", "type"=>"BACKGROUND", "citation"=>"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."}]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nCouples 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.\n\nParticipants 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.\n\nParticipants 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.\n\nSource 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.\n\nAt 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.\n\nAll participants will be asked to complete a questionnaire for gathering information about people with genital herpes and people at risk for the infection.", "detailedDescription"=>"This is a randomized, multicenter, double-blind, placebo-controlled Phase III study to evaluate the effect of valaciclovir in preventing the transmission of herpes simplex virus (HSV) in heterosexual couples discordant for the presence of herpes simplex type 2 virus (HSV-2) antibody. The seropositive source partner will be randomized to receive valaciclovir 500 mg once daily or placebo for 8 months, and the susceptible seronegative partner will be monitored for clinical and subclinical (serological) acquisition of HSV. Couples must be 18 years of age or older, in general good health, and in a monogamous relationship with each other. Source partners must be seropositive for HSV-2, have a history of genital herpes recurrences, and experiencing less than 10 recurrences per year, and be off suppressive therapy upon entry into the study. Susceptible partners must be HSV-2 seronegative. The couple will be stratified based on gender and HSV status of the susceptible partner in a 2:2:1:1 ratio \\[HSV-1 negative female: HSV-1 positive female: HSV-1 negative male: HSV-1 positive male\\]. They will then be randomized to either valaciclovir 500 mg once daily or placebo (1:1 randomization) within each stratum. The primary endpoint is the proportion of couples with clinical evidence of a first episode of genital HSV in the susceptible partner with laboratory confirmation. Secondary endpoints will be time to clinical symptoms of genital HSV by the susceptible partner, time to seroconversion in the susceptible partner, and time to first recurrence of HSV in the source partner. A total of 1500 couples will be randomized into the study. Assuming a 3% incidence in the placebo arm and a reduction of 75% in the risk of showing clinical evidence of genital HSV, this study will have at least 80% power for a two-tailed test at the 5% level of significance. The safety and tolerance of valaciclovir will be assessed by laboratory evaluation and by occurrence and nature of adverse events. The study will be conducted at approximately 35 outpatient centers in the United States, Canada and Europe, therefore it is expected that each center will enroll between 40 to 60 couples."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"INCLUSION CRITERIA - SOURCE PARTNER\n\n18 years of age or older.\n\nGeneral good health as determined by current medical status and laboratory tests.\n\nActive heterosexual relationship with susceptible partner.\n\nPresence of HSV-2 serum antibody as determined by Western blot analysis.\n\nHistory of symptomatic recurrent genital herpes.\n\nOff HSV suppressive therapy upon entering study.\n\nIn the opinion of the investigator, able to comply with protocol requirements.\n\nIn the investigator's opinion, subjects must be candidates for receiving suppressive therapy for management of their disease.\n\nWritten informed consent.\n\nEXCLUSION CRITERIA - SOURCE PARTNER:\n\nPatients who are known or suspected to be immunocompromised (e.g., patients receiving immunosuppressive therapy, patients with malignancy or seropositive for HIV).\n\nSubjects with a history of 10 or more HSV recurrences per year.\n\nImpaired renal function as defined by serum creatinine greater than 1.5 mg/dL or estimated creatinine clearance less than 30 ml/min.\n\nImpaired hepatic function defined as an alanine transaminase (ALT) level greater than 3 times the normal upper limit.\n\nKnown resistance to aciclovir, famciclovir, or ganciclovir.\n\nKnown hypersensitivity to aciclovir, valaciclovir, famciclovir, or ganciclovir.\n\nMalabsorption syndrome or other gastrointestinal dysfunction that might impair drug dynamics.\n\nSubjects known to be lactose intolerant.\n\nWomen contemplating pregnancy within the duration of study drug dosing for this study.\n\nWomen of child bearing potential not using an effective method of contraception.\n\nPositive pregnancy test (or pregnant females or nursing mothers).\n\nINCLUSION CRITERIA - SUSCEPTIBLE PARTNER\n\n18 years of age or older.\n\nGeneral good health as determined by current medical status.\n\nActive monogamous, heterosexual relationship with source partner.\n\nAbsence of HSV-2 serum antibody as determined by Western blot analysis.\n\nIn the investigator's opinion, able to comply with protocol requirements.\n\nWritten informed consent.\n\nEXCLUSION CRITERIA - SUSCEPTIBLE PARTNER:\n\nSubjects who are known or suspected to be immunocompromised (e.g., patients receiving immunosuppressive therapy, patients with malignancy or seropositive for HIV).\n\nSubjects who have received an active HSV vaccine (subjects known to have received placebo in clinical trials are eligible).\n\nPresence of symptomatic genital herpes.\n\nSubjects having sexual relations with anyone other than the source partner.\n\nWomen contemplating pregnancy within the time period of the study.\n\nWomen of childbearing potential not using an effective method of contraception.\n\nPositive pregnancy test (or pregnant females or nursing mothers)."}, "identificationModule"=>{"nctId"=>"NCT00001649", "briefTitle"=>"Valaciclovir to Prevent Transmission of Herpes Simplex Virus", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Randomized, Double-Blind, Placebo-Controlled Evaluation of Valaciclovir for the Prevention of Herpes Simplex Virus Transmission in Heterosexual Couples", "orgStudyIdInfo"=>{"id"=>"970168"}, "secondaryIdInfos"=>[{"id"=>"97-I-0168"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Valaciclovir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
