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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valaciclovir | Drug | 1g once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 168 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| HS2100275 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 384 participants with first recognized episode of genital herpes (GH) were randomized in this study, out of which one participant did not take the study medication, hence, the Intent-to-treat (ITT) population consisted of 383 participants.
The study was conducted in 74 centers in the Unites States, Canada, Argentina, Brazil, and Chile.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg twice a day (BID) for 3 days after which the double-blind therapy was resumed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
placebo |
|
| 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. | 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. | 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. | Day 168 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85710 | United States |
| GSK Investigational Site | Anaheim | California | 92805 | United States |
| GSK Investigational Site | Beverly Hills | California | 90211 | United States |
| GSK Investigational Site | Davis | California | 95616 | United States |
| GSK Investigational Site | Fair Oaks | California | 95628 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Sacramento | California | 95816 | United States |
| GSK Investigational Site | Sacramento | California | 95825 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | San Diego | California | 92128 | United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | Santa Ana | California | 92704 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06012 | United States |
| GSK Investigational Site | New Britain | Connecticut | 06052 | United States |
| GSK Investigational Site | Clearwater | Florida | 33759 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | Palm Springs | Florida | 33461 | United States |
| GSK Investigational Site | Venice | Florida | 34285 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | United States |
| GSK Investigational Site | Alpharetta | Georgia | 30005 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30310 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Springfield | Illinois | 62702 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 - 5124 | United States |
| GSK Investigational Site | South Bend | Indiana | 46601 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70114 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114 | United States |
| GSK Investigational Site | Taunton | Massachusetts | 02780 | United States |
| GSK Investigational Site | Portage | Michigan | 49024 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89128 | United States |
| GSK Investigational Site | Brooklyn | New York | 11203 | United States |
| GSK Investigational Site | Endicott | New York | 13760 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794-8091 | United States |
| GSK Investigational Site | The Bronx | New York | 10461 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| GSK Investigational Site | East Providence | Rhode Island | 02914 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38104 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38120 | United States |
| GSK Investigational Site | Austin | Texas | 78746 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Georgetown | Texas | 78626 | United States |
| GSK Investigational Site | Houston | Texas | 77058 | United States |
| GSK Investigational Site | San Antonio | Texas | 78205 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | La Crosse | Wisconsin | 54601 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53209-0996 | United States |
| GSK Investigational Site | Waukesha | Wisconsin | 53186 | United States |
| GSK Investigational Site | Buenos Aires | 1221 | Argentina |
| GSK Investigational Site | Buenos Aires | C1114AAP | Argentina |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90470-340 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 20 551-030 | Brazil |
| GSK Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1S 0G8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5V 2T3 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Québec | G1S 2L6 | Canada |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7580206 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 8380456 | Chile |
For additional information about this study please refer to the GSK Clinical Study Register |
| HS2100275 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS2100275 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS2100275 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS2100275 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS2100275 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HS2100275 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Valaciclovir 1g QD | 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). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to this treatment arm received matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. |
| BG001 | Valaciclovir 1g QD | 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). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500mg BID for 3 days after which the double-blind therapy was resumed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product. | Posted | Number | Percentage of participants | Day 168 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Number of recurrences | Up to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population | Posted | Count of Participants | Participants | Upto Day 168 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population | Posted | Number | Percentage of participants | Day 168 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. | Posted | Number | Number of isolates | Day 168 |
|
AEs were collected up to end of study (Day 168).
ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product. ITT population was used for reporting adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. | 0 | 128 | 4 | 128 | 75 | 128 |
| EG001 | Valaciclovir 1g QD | 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). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. | 1 | 255 | 3 | 255 | 138 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 9.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA version 9.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Arabic/North African |
|
| Black |
|
| East & South East Asian |
|
| White/Caucasian |
|
| Unknown |
|
| Hazard Ratio (HR) |
| 0.401 |
| 2-Sided |
| 95 |
| 0.282 |
| 0.570 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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