Last updated: 11/21/2020 12:10:31
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Adverse Events
Timeframe: Up to 6 months
Secondary outcomes:
Proportion of recurrence of genital HSV
Timeframe: Up to 6 months
Time to first culture-positive recurrence of genital HSV
Timeframe: Up to 6 months
Interventions:
Drug: valacyclovir hydrochloride
Enrollment:
7
Observational study model:
Not applicable
Primary completion date:
2004-15-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Genitalis
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
March 2004 to October 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- CD4+ lymphocyte count <100cells/mm3 at the screening visit.
- Documented history of HIV infections
- Kidney diseases.
- Liver diseases.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60657
Status
Study Complete
Location
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2004-15-10
Actual study completion date
2004-15-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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