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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.