---
title: Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
nct_id: NCT01047540
overall_status: COMPLETED
phase: PHASE2
sponsor: AiCuris Anti-infective Cures AG
study_type: INTERVENTIONAL
primary_condition: HSV-2
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01047540.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01047540"
ct_last_update_post_date: 2023-04-21
last_seen_at: "2026-05-12T06:50:18.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2

**Official Title:** A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection

**NCT ID:** [NCT01047540](https://clinicaltrials.gov/study/NCT01047540)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 156
- **Lead Sponsor:** AiCuris Anti-infective Cures AG
- **Collaborators:** FHI 360
- **Conditions:** HSV-2
- **Start Date:** 2010-03
- **Completion Date:** 2011-03
- **CT.gov Last Update:** 2023-04-21

## Brief 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **Dose regimen 1** (EXPERIMENTAL)
- **Dose regimen 2** (EXPERIMENTAL)
- **Dose regimen 3** (EXPERIMENTAL)
- **Dose regimen 4** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **AIC316** (DRUG) — Oral administration
- **AIC316** (DRUG) — Oral administration
- **AIC316** (DRUG) — Oral administration
- **AIC316** (DRUG) — Oral administration
- **Placebo** (DRUG) — Oral administration

## Primary Outcomes

- **Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)** _(time frame: 28 days)_ — Subjects were assessed for shedding rate as the percentage of number of swab days with at least one swab positive for HSV DNA relative to the total number of days with analyzable swabs. Measurement was based on presence of HSV DNA measured on the material collected from swabs taken at the visits by the investigator and daily swabbing of the anogenital region by the patient during the treatment and post-treatment period.

## Locations (6)

- Cetero Research Miami Gardens, Miami, Florida, United States
- Indiana University School of Medicine, Office for Research, Indianapolis, Indiana, United States
- Westover Heights Clinic, Portland, Oregon, United States
- University of Texas Health Science Centre, Center for Clincial Studies, Houston, Texas, United States
- University of Utah, Salt Lake City, Utah, United States
- University of Washington, Virology Research Clinic, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cetero research miami gardens|miami|florida|united states` — added _(2026-05-12)_
- `locations.indiana university school of medicine, office for research|indianapolis|indiana|united states` — added _(2026-05-12)_
- `locations.westover heights clinic|portland|oregon|united states` — added _(2026-05-12)_
- `locations.university of texas health science centre, center for clincial studies|houston|texas|united states` — added _(2026-05-12)_
- `locations.university of utah|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.university of washington, virology research clinic|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01047540.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01047540*  
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