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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00079911




Trial ID
NCT00079911
Ethics application status
Date submitted
18/03/2004
Date registered
18/03/2004
Date last updated
3/08/2017

Titles & IDs
Public title
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
Scientific 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.
Secondary ID [1] 0 0
100181
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Genitalis 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - valacyclovir hydrochloride

Experimental: Suppressive + Episodic Therapy - Valaciclovir (VAL) 500mg twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 days or 10 days, when required for treatment of a genital herpes recurrence.

Placebo Comparator: Episodic Therapy - Matching placebo twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 or 10 days, when required for treatment of a genital herpes recurrence.


Treatment: Drugs: valacyclovir hydrochloride
valacyclovir hydrochloride

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events - The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
Timepoint [1] 0 0
Up to 6 months
Secondary outcome [1] 0 0
Proportion of recurrence of genital HSV - Secondary outcome measures are the proportion of subjects recurrence-free of genital HSV at 6 months, and the time to first culture-positive recurrence of genital HSV.
Timepoint [1] 0 0
Up to 6 months
Secondary outcome [2] 0 0
Time to first culture-positive recurrence of genital HSV - Secondary outcome measures are the proportion of subjects recurrence-free of genital HSV at 6 months, and the time to first culture-positive recurrence of genital HSV.
Timepoint [2] 0 0
Up to 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Hong Kong
State/province [9] 0 0
Kowloon Bay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 herpes infections in HIV-infected subjects with CD4+ count <100
cells/mm3.
Trial website
https://clinicaltrials.gov/show/NCT00079911
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries