Phase 2
Completed N=156
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
HSV-2
Source: ClinicalTrials.gov NCT01047540 ↗
Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate) — 21.2; 9.2; 2.0; 5.2 percentage of swab days
Summary
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate) |
21.2; 9.2; 2.0; 5.2; 16.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult, Immunocompetent men and women in good health of any ethnic group
- History of recurrent episodes of genital herpes for at least 12 months
- Seropositive for Herpes Simplex Virus HSV Type 2
- Body Mass Index (BMI) between 18 and 35 kg/m2
Exclusion Criteria
- Present episode of genital herpes
- Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
- Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
- Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Data sourced from ClinicalTrials.gov (NCT01047540). 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.