Herpes GenitalisPhase 4NCT00079911
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
A Phase 4 study testing valacyclovir hydrochloride in people with Herpes Genitalis, run by GlaxoSmithKline at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Genitalis
- What is being tested?
- valacyclovir hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 12 Mar 2004to 15 Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
GSK Investigational Site
Altamonte Springs, Florida, 32701
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Chicago, Illinois, 60657
Australia1 site
GSK Investigational Site
Darlinghurst, New South Wales, 2010
About this study
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.
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.
- Conditions
- Herpes Genitalis
- Being tested
- valacyclovir hydrochloride
- Keywords
- Herpes, Genital Herpes, HIV, HSV
- Medical subject headings
- Herpes Genitalis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valacyclovir hydrochlorideDrug
valacyclovir hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Suppressive + Episodic Therapy | Experimental | 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. Receives: Drug: valacyclovir hydrochloride |
| Episodic Therapy | Placebo comparator | 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. Receives: Drug: valacyclovir hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
Measured: Up to 6 months
Secondary outcomes (2)
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2004 (estimated)
- Study start12 Mar 2004
- Primary completion15 Oct 2004
- Study completion15 Oct 2004
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes GenitalisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079911
- Sponsor's protocol ID
- 100181
- Status last verified
- Nov 2020
- First submitted
- 18 Mar 2004
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00079911
- Acronym / sponsor ID
- 100181
- Conditions
- Herpes Genitalis
- Keywords
- Herpes, Genital Herpes, HIV, HSV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2004 (actual)
- Primary completion
- 15 Oct 2004 (actual)
- Study completion
- 15 Oct 2004 (actual)
- First posted
- 19 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suppressive + Episodic Therapy | Experimental | Drug: valacyclovir hydrochlorideValaciclovir (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. |
| Episodic Therapy | Placebo comparator | Drug: valacyclovir hydrochlorideMatching 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valacyclovir hydrochloridevalacyclovir hydrochloride | Drug | Episodic Therapy, Suppressive + Episodic Therapy |
Primary outcome
Adverse Events
Time frame: Up to 6 months
The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
2 secondary outcomes
Proportion of recurrence of genital HSV
Time frame: Up to 6 months
Time to first culture-positive recurrence of genital HSV
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valacyclovir hydrochloride in people with Herpes Genitalis, run by GlaxoSmithKline at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.