Status:
TERMINATED
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Genitalis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2004
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00079911
Start Date
March 12 2004
End Date
October 15 2004
Last Update
November 24 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
2
GSK Investigational Site
Chicago, Illinois, United States, 60657
3
GSK Investigational Site
Boston, Massachusetts, United States, 02115
4
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010