Herpes GenitalisPhase 4NCT00158860

A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.

A Phase 4 study testing Valaciclovir in people with Herpes Genitalis, run by GlaxoSmithKline at 72 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Herpes Genitalis
What is being tested?: Valaciclovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 384 participants
Where: 72 sitesin 5 countries
Study dates: 21 Jun 2004to 26 Jul 2006
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

In overall general good health.
Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.

Who cannot join

Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
Received an investigational drug in the 30 days prior to the study.
Receiving systemic antiviral or immunomodulatory treatments.
Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula.
Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit.

Show all 14Show fewer

Subjects with active liver disease.
Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
Women contemplating pregnancy within the duration of the study drug dosing period.
Women who are pregnant and/or nursing mothers
Current history of alcohol or drug abuse.
Received suppressive (daily) therapy for genital herpes prior to enrollment.

Trial locations and contacts

72 sites in 5 countries.

Country

City, postcode or hospital

72 sites in 5 countries

United States58 sites

GSK Investigational Site
Alpharetta, Georgia, 30005
GSK Investigational Site
Anaheim, California, 92805
GSK Investigational Site
Atlanta, Georgia, 30310
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Austin, Texas, 78746
GSK Investigational Site
Beverly Hills, California, 90211
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Brooklyn, New York, 11203
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Clearwater, Florida, 33759
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Davis, California, 95616
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
Endicott, New York, 13760
GSK Investigational Site
Fair Oaks, California, 95628
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Georgetown, Texas, 78626
GSK Investigational Site
Hartford, Connecticut, 06012
GSK Investigational Site
Houston, Texas, 77058
GSK Investigational Site
Indianapolis, Indiana, 46202 - 5124
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
Las Vegas, Nevada, 89128
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Memphis, Tennessee, 38104
GSK Investigational Site
Memphis, Tennessee, 38120
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996
GSK Investigational Site
New Britain, Connecticut, 06052
GSK Investigational Site
New Orleans, Louisiana, 70114
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Palm Springs, Florida, 33461
GSK Investigational Site
Philadelphia, Pennsylvania, 19103
GSK Investigational Site
Phoenix, Arizona, 85016
GSK Investigational Site
Portage, Michigan, 49024
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Sacramento, California, 95816
GSK Investigational Site
Sacramento, California, 95825
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Diego, California, 92128
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
Santa Ana, California, 92704
GSK Investigational Site
South Bend, Indiana, 46601
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Springfield, Illinois, 62702
GSK Investigational Site
Stony Brook, New York, 11794-8091
GSK Investigational Site
Taunton, Massachusetts, 02780
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Tucson, Arizona, 85710
GSK Investigational Site
Tulsa, Oklahoma, 74104
GSK Investigational Site
Venice, Florida, 34285
GSK Investigational Site
Waukesha, Wisconsin, 53186
GSK Investigational Site
West Palm Beach, Florida, 33407
GSK Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada7 sites

GSK Investigational Site
Edmonton, Alberta, T6G 2C8
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Ottawa, Ontario, K1S 0G8
GSK Investigational Site
Québec, G1S 2L6
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Toronto, Ontario, M5V 2T3
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Brazil3 sites

GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90470-340
GSK Investigational Site
Rio de Janeiro, 20 551-030

Other trials in Brazil

Argentina2 sites

GSK Investigational Site
Buenos Aires, 1221
GSK Investigational Site
Buenos Aires, C1114AAP

Other trials in Argentina

Chile2 sites

GSK Investigational Site
Santiago, Región Metro de Santiago, 7580206
GSK Investigational Site
Santiago, Región Metro de Santiago, 8380456

Other trials in Chile

About this study

Official title: An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-Month Study of the Efficacy and Safety of Valtrex 1g QD vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Patients

Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.

Conditions: Herpes Genitalis
Being tested: Valaciclovir, Placebo
Keywords: VALTREX®, valaciclovir, genital herpes, HSV-2, suppression
Medical subject headings: Herpes Genitalis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ValaciclovirDrug
1g once daily
PlaceboDrug
placebo

Study groups in NCT00158860
Study group	Role	What they receive
Valaciclovir	Experimental	Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Receives: Drug: Valaciclovir
Placebo	Placebo comparator	Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Time to First GH Recurrence
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.
Measured: Day 168

Secondary outcomes (4)

Mean Number of GH Recurrences Per Month Within the 6-month Study Period
Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant.
Measured: Up to Day 168
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant.
Measured: Upto Day 168
Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
Diary cards were issued to the participants during randomization visit for recording HSV outbreak within 6-momths. HSV outbreak was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported.
Measured: Day 168
Number of Isolates With Resistance to Acyclovir (ACV)
Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV.
Measured: Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 200426 Jul 2006

First posted12 Sep 2005 (estimated)
Study start21 Jun 2004
Primary completion26 Jul 2006
Study completion26 Jul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Single blind
Who is masked: Investigator
Enrolment: 384 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00158860
Sponsor's protocol ID: HS2100275
Status last verified: Dec 2017
First submitted: 8 Sep 2005
Last updated: 15 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
Enrolling by invitationPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
Genital Herpes
Not yet recruitingPhase 2
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
Recurrent Genital Herpes

All Herpes Genitalis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-Month Study of the Efficacy and Safety of Valtrex 1g QD vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Patients
ClinicalTrials.gov ID: NCT00158860
Acronym / sponsor ID: HS2100275
Conditions: Herpes Genitalis
Keywords: VALTREX®, valaciclovir, genital herpes, HSV-2, suppression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 384 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 21 Jun 2004 (actual)
Primary completion: 26 Jul 2006 (actual)
Study completion: 26 Jul 2006 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Valaciclovir	Experimental	Drug: ValaciclovirParticipants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks).
Placebo	Placebo comparator	Drug: PlaceboParticipants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

In overall general good health.
Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.

Key exclusion criteria (14 listed)

Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
Received an investigational drug in the 30 days prior to the study.
Receiving systemic antiviral or immunomodulatory treatments.
Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula.

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
Valaciclovir1g once daily	Drug	Valaciclovir
Placeboplacebo	Drug	Placebo

Primary outcome

Percentage of Participants With Time to First GH Recurrence
Time frame: Day 168
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.

4 secondary outcomes

Mean Number of GH Recurrences Per Month Within the 6-month Study Period
Time frame: Up to Day 168
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Upto Day 168
Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
Time frame: Day 168
Number of Isolates With Resistance to Acyclovir (ACV)
Time frame: Day 168

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	128	93
Valaciclovir 1g QD	255	184

Primary outcome: Percentage of Participants With Time to First GH Recurrence

Time frame: Day 168. Number. Unit: Percentage of participants

Measure	Placebo n = 128	Valaciclovir 1g QD n = 255
Value	43	71

Placebo vs Valaciclovir 1g QD: Kaplan-Meier estimates: 27.3 (95% CI 16.0 to 38.6), p <0.001, Log Rank
Placebo vs Valaciclovir 1g QD: Hazard Ratio (HR): 0.401 (95% CI 0.282 to 0.570), p <0.001, Log Rank

Population analysed: ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected up to end of study (Day 168).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 128 (3.1%)	75 of 128 (58.6%)	0 of 128
Valaciclovir 1g QD	3 of 255 (1.2%)	138 of 255 (54.1%)	1 of 255

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Herpes Genitalis

Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
Enrolling by invitationPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
Genital Herpes
Not yet recruitingPhase 2
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
Recurrent Genital Herpes

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

72 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Valaciclovir in people with Herpes Genitalis, run by GlaxoSmithKline at 72 sites in 5 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Canada, Brazil, Argentina, Chile. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Time to First GH Recurrence (time frame: Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00158860.

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 15 Feb 2019.