A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
23. juni 2005 opdateret af: Glaxo Wellcome
An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months.
Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence.
Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated.
For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence.
Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator.
If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation.
Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator.
Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months).
The total duration of the study for all patients is 6 months.
Undersøgelsestype
Interventionel
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Edmonton, Alberta, Canada
- Dr Barbara Romanowski
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Ontario
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Toronto, Ontario, Canada
- Sunnybrook Health Science Ctr
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Quebec
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Montreal, Quebec, Canada
- Clinique Medicale L'Actuele
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Ste Foy, Quebec, Canada
- Centre De Recherche En Infectiologie
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California
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Berkeley, California, Forenede Stater, 94705
- East Bay AIDS Ctr
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Beverly Hills, California, Forenede Stater, 90211
- Pacific Oaks Research
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Los Angeles, California, Forenede Stater, 90036
- Kraus Med Partners
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San Francisco, California, Forenede Stater, 94109
- ViRx Inc
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Florida
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Altamonte Springs, Florida, Forenede Stater, 32701
- IDC Research Initiative
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Healthnet Institute
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Miami, Florida, Forenede Stater, 331361013
- Univ of Miami School of Medicine
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Vero Beach, Florida, Forenede Stater, 32960
- Treasure Coast Infectious Disease Consultants
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West Palm Beach, Florida, Forenede Stater, 33409
- Palm Beach Research Ctr
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana Univ School of Medicine / Dept of Infect Dis
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- Univ of Minnesota
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Advanced Biomedical Research Inc
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28207
- Nalle Clinic / Clinical Research Dept
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Raleigh, North Carolina, Forenede Stater, 27610
- Wake County Dept of Health
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Westover Heights Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Philadelphia FIGHT
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02907
- Dr Alvan Fisher
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Texas
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Houston, Texas, Forenede Stater, 770303498
- Baylor College of Medicine / Dept of Medicine
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Virginia
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Richmond, Virginia, Forenede Stater, 23219
- Richmond AIDS Consortium
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Washington
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Seattle, Washington, Forenede Stater, 98122
- Univ of Washington Virology Research Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Have herpes simplex virus (HSV) 2.
- Have received combination anti-HIV therapy for at least 2 months before entering the study.
- Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
- Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.)
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have blood vessel disease.
- Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
- Are unable to take medications by mouth.
- Have non-healed sores on the anus or genitals at beginning of study.
- Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
- Are using interferon. Patients receiving interferon must stop interferon before beginning the study.
- Have kidney or liver problems.
- Are pregnant or breast-feeding.
- Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 1999
Datoer for studieregistrering
Først indsendt
11. maj 2000
Først indsendt, der opfyldte QC-kriterier
30. august 2001
Først opslået (Skøn)
31. august 2001
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juni 2005
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2005
Sidst verificeret
1. juli 2001
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 104C
- HS230018
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