A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-In… (NCT00079911) | Clinical Trial Compass
TerminatedPhase 4
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
Stopped: Terminated
United States, Australia, Hong Kong7 participantsStarted 2004-03-12
Plain-language summary
This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count \<100 cells/mm3.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* CD4+ lymphocyte count \<100cells/mm3 at the screening visit.
* Documented history of HIV infections
* Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study.
* Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test).
* 3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
* 3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.
Exclusion Criteria:
* Kidney diseases.
* Liver diseases.
* Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir).
* Vomiting syndrome.
* Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation.
* Active AIDS-indicator conditions, as defined by CDC Category C.
* Other protocol inclusion and exclusion criteria to be evaluated by the research physician.