NCT01047540

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
10.9 years until next milestone

Results Posted

Study results publicly available

February 4, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

January 12, 2010

Results QC Date

January 6, 2022

Last Update Submit

April 14, 2023

Conditions

HSV-2

Outcome Measures

Primary Outcomes (1)

  • Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)

    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.

    28 days

Study Arms (5)

Dose regimen 1

EXPERIMENTAL
Drug: AIC316

Dose regimen 2

EXPERIMENTAL
Drug: AIC316

Dose regimen 3

EXPERIMENTAL
Drug: AIC316

Dose regimen 4

EXPERIMENTAL
Drug: AIC316

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AIC316DRUG

Oral administration

Also known as: pritelivir
Dose regimen 1
PlaceboDRUG

Oral administration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cetero Research Miami Gardens

Miami, Florida, 33169, United States

Location

Indiana University School of Medicine, Office for Research

Indianapolis, Indiana, 46202, United States

Location

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

University of Texas Health Science Centre, Center for Clincial Studies

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Washington, Virology Research Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Wald A, Corey L, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Kriesel J, Fife K, Galitz L, Stoelben S, Huang ML, Selke S, Stobernack HP, Ruebsamen-Schaeff H, Birkmann A. Helicase-primase inhibitor pritelivir for HSV-2 infection. N Engl J Med. 2014 Jan 16;370(3):201-10. doi: 10.1056/NEJMoa1301150.

    PMID: 24428466DERIVED

MeSH Terms

Interventions

pritelivir

Results Point of Contact

Title
Information Desk
Organization
AiCuris Anti-infective Cures GmbH
info@aicuris.com
+4920231763

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

April 21, 2023

Results First Posted

February 4, 2022

Record last verified: 2023-04

Locations

US(6)