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

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

This study is currently recruiting participants.

Verified by AiCuris GmbH & Co.KG, June 2010

First Received: January 12, 2010   Last Updated: June 11, 2010   History of Changes

Sponsor:

AiCuris GmbH & Co.KG

Collaborator:

Family Health International

Information provided by:

AiCuris GmbH & Co.KG

ClinicalTrials.gov Identifier:

NCT01047540

Purpose

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


Condition

Intervention

Phase

HSV-2

Drug: AIC316

Drug: Placebo

Phase II


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Prevention

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


Further study details as provided by AiCuris GmbH & Co.KG:


Primary Outcome Measures:

Compare the efficacy of 4 different doses of AIC316 and matching placebo with respect to the suppression of herpes simplex virus replication [ Time Frame: 28 days ] [ Designated as safety issue: No ]


Estimated Enrollment:

150

Study Start Date:

March 2010

Estimated Study Completion Date:

March 2011

Estimated Primary Completion Date:

December 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Dose regimen 1: Experimental

Drug: AIC316

Oral administration

Dose regimen 2: Experimental

Drug: AIC316

Oral administration

Dose regimen 3: Experimental

Drug: AIC316

Oral administration

Dose regimen 4: Experimental

Drug: AIC316

Oral administration

Placebo: Placebo Comparator

Drug: Placebo

Oral administration


Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047540


Contacts

Contact: Susanne Stoelben, MD, MPH

+49-202-31763 ext 2119

Susanne.stoelben@aicuris.com


Locations

United States, Florida

Cetero Research Miami Gardens

Not yet recruiting

Miami, Florida, United States, 33169

United States, Indiana

Indiana University School of Medicine, Office for Research

Recruiting

Indianapolis, Indiana, United States, 46202

United States, Oregon

Westover Heights Clinic

Recruiting

Portland, Oregon, United States, 97210

United States, Texas

University of Texas Health Science Centre, Center for Clincial Studies

Recruiting

Houston, Texas, United States, 77030

United States, Utah

University of Utah

Not yet recruiting

Salt Lake City, Utah, United States, 84132

United States, Washington

University of Washington, Virology Research Clinic

Not yet recruiting

Seattle, Washington, United States, 98104

Sponsors and Collaborators

AiCuris GmbH & Co.KG

Family Health International

More Information


No publications provided


Responsible Party:

AiCuris GmbH & Co.KG ( Susanne Stoelben, MD, MPH, Head of Clinical Investigations & Clinical Operations Phase II, III )

ClinicalTrials.gov Identifier:

NCT01047540 History of Changes

Other Study ID Numbers:

AIC316-01-II-01

Study First Received:

January 12, 2010

Last Updated:

June 11, 2010

Health Authority:

United States: Food and Drug Administration


Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions


ClinicalTrials.gov processed this record on June 15, 2010

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

This study is currently recruiting participants.

Verified by AiCuris GmbH & Co.KG, June 2010

First Received: January 12, 2010   Last Updated: June 11, 2010   History of Changes

Sponsor:

AiCuris GmbH & Co.KG

Collaborator:

Family Health International

Information provided by:

AiCuris GmbH & Co.KG

ClinicalTrials.gov Identifier:

NCT01047540

Purpose

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


Condition

Intervention

Phase

HSV-2

Drug: AIC316

Drug: Placebo

Phase II


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Prevention

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


Further study details as provided by AiCuris GmbH & Co.KG:


Primary Outcome Measures:

Compare the efficacy of 4 different doses of AIC316 and matching placebo with respect to the suppression of herpes simplex virus replication [ Time Frame: 28 days ] [ Designated as safety issue: No ]


Estimated Enrollment:

150

Study Start Date:

March 2010

Estimated Study Completion Date:

March 2011

Estimated Primary Completion Date:

December 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Dose regimen 1: Experimental

Drug: AIC316

Oral administration

Dose regimen 2: Experimental

Drug: AIC316

Oral administration

Dose regimen 3: Experimental

Drug: AIC316

Oral administration

Dose regimen 4: Experimental

Drug: AIC316

Oral administration

Placebo: Placebo Comparator

Drug: Placebo

Oral administration


Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047540


Contacts

Contact: Susanne Stoelben, MD, MPH

+49-202-31763 ext 2119

Susanne.stoelben@aicuris.com


Locations

United States, Florida

Cetero Research Miami Gardens

Not yet recruiting

Miami, Florida, United States, 33169

United States, Indiana

Indiana University School of Medicine, Office for Research

Recruiting

Indianapolis, Indiana, United States, 46202

United States, Oregon

Westover Heights Clinic

Recruiting

Portland, Oregon, United States, 97210

United States, Texas

University of Texas Health Science Centre, Center for Clincial Studies

Recruiting

Houston, Texas, United States, 77030

United States, Utah

University of Utah

Not yet recruiting

Salt Lake City, Utah, United States, 84132

United States, Washington

University of Washington, Virology Research Clinic

Not yet recruiting

Seattle, Washington, United States, 98104

Sponsors and Collaborators

AiCuris GmbH & Co.KG

Family Health International

More Information


No publications provided


Responsible Party:

AiCuris GmbH & Co.KG ( Susanne Stoelben, MD, MPH, Head of Clinical Investigations & Clinical Operations Phase II, III )

ClinicalTrials.gov Identifier:

NCT01047540 History of Changes

Other Study ID Numbers:

AIC316-01-II-01

Study First Received:

January 12, 2010

Last Updated:

June 11, 2010

Health Authority:

United States: Food and Drug Administration


Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions


ClinicalTrials.gov processed this record on June 15, 2010