Phase 4
Completed N=71
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Infections, Herpesviridae
Source: ClinicalTrials.gov NCT00116844 ↗
Enrolled (actual)
71
Serious AEs
0.8%
Results posted
Feb 2018
Primary outcomePrimary: Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2 — 1.5; 5.1 Percentage of days — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2 |
1.5; 5.1 | <0.001 sig |
| SECONDARY Mean Percent Days of Total HSV-2 Shedding |
1.5; 5.5 | <0.001 sig |
| SECONDARY Number of Participants With no Shedding |
47; 30; 9; 26 | <0.001 sig |
| SECONDARY Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding |
4.5; 4.6 | 0.800 |
| SECONDARY Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding |
4.5; 5.2 | 0.229 |
| SECONDARY Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study |
88; 77; 13; 23 | 0.0331 sig |
Eligibility Criteria
Inclusion Criteria
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
Exclusion criteria
- have active lesions consistent with genital herpes.
- previous history of symptomatic genital herpes.
- history of recurrent, undiagnosed symptoms consistent with genital herpes.
Data sourced from ClinicalTrials.gov (NCT00116844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.