Phase 2 N=156 Randomized Quadruple-blind Prevention

Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2

HSV-2

Bottom Line

View on ClinicalTrials.gov: NCT01047540 ↗

Enrolled (actual)

156

Serious AEs

0.0%

Results posted

Feb 2022

Primary outcome: 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 percentage of swab days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AIC316 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AiCuris Anti-infective Cures AG
Primary completion: Dec 2010

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	—

Summary

The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes

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)

View full record on ClinicalTrials.gov →

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.