NCT00158860

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.

Completed Phase 4 Results posted Last updated 15 February 2019

What this trial tests

Phase 4 trial testing Valaciclovir in Herpes Genitalis in 384 participants. Completed in 26 July 2006.

Timeline

21 June 2004

Primary endpoint
26 July 2006

26 July 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	384
Start date	21 June 2004
Primary completion	26 July 2006
Estimated completion	26 July 2006
Sites	72 locations across Chile, Argentina, Canada, United States, Brazil

Drugs / interventions tested

• Valaciclovir (valaciclovir) — full drug profile →
• Placebo

Conditions studied

• Herpes Genitalis — all drugs for Herpes Genitalis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Herpes Genitalis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Time to First GH Recurrence Primary · 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.

Group	Value	95% CI
Placebo	43
Valaciclovir 1g QD	71

Mean Number of GH Recurrences Per Month Within the 6-month Study Period Secondary · Up to Day 168

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.

Group	Value	95% CI
Placebo	0.48	± 1.860
Valaciclovir 1g QD	0.11	± 0.254

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Upto Day 168

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.

Any AEs

Group	Value	95% CI
Placebo	98
Valaciclovir 1g QD	185

Any SAEs

Group	Value	95% CI
Placebo	4
Valaciclovir 1g QD	3

Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months Secondary · Day 168

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.

Group	Value	95% CI
Placebo	11
Valaciclovir 1g QD	14

Number of Isolates With Resistance to Acyclovir (ACV) Secondary · Day 168

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.

Group	Value	95% CI
Placebo	0
Valaciclovir 1g QD	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected up to end of study (Day 168).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 4/128 (3%)

Deaths: 0/128

Valaciclovir 1g QD

Serious: 3/255 (1%)

Deaths: 1/255

Serious adverse events (5 terms)

Reaction	System	Placebo	Valaciclovir 1g QD
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—
Appendicitis	Infections and infestations	—	—
Gun shot wound	Injury, poisoning and procedural complications	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Placebo	Valaciclovir 1g QD
Headache	Nervous system disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Herpes simplex	Infections and infestations	—	—
Vulvovaginal mycotic infection	Infections and infestations	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Influenza	Infections and infestations	—	—

Most-reported serious reactions: Abortion spontaneous, Appendicitis, Gun shot wound, Hypokalaemia, Lymphoma.

Data from ClinicalTrials.gov NCT00158860 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.