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| Name | Class |
|---|---|
| FHI 360 | OTHER |
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The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose regimen 1 | Experimental |
| |
| Dose regimen 2 | Experimental |
| |
| Dose regimen 3 | Experimental |
| |
| Dose regimen 4 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIC316 | Drug | Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research Miami Gardens | Miami | Florida | 33169 | United States | ||
| Indiana University School of Medicine, Office for Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24428466 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Regimen 1 | AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration |
| FG001 | Dose Regimen 2 | AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration |
| FG002 | Dose Regimen 3 | AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration |
| FG003 | Dose Regimen 4 | AIC316: 400 mg QWK, Oral administration |
| FG004 | Placebo | Matching placebo: Oral administration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Based on Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Regimen 1 | AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration |
| BG001 | Dose Regimen 2 | AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of swab days | 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Regimen 1 | AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Information Desk | AiCuris Anti-infective Cures GmbH | +4920231763 | 0 | info@aicuris.com |
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| ID | Term |
|---|---|
| C453221 | pritelivir |
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| AIC316 | Drug | Oral administration |
|
|
| AIC316 | Drug | Oral administration |
|
|
| AIC316 | Drug | Oral administration |
|
|
| Placebo | Drug | Oral administration |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Westover Heights Clinic | Portland | Oregon | 97210 | United States |
| University of Texas Health Science Centre, Center for Clincial Studies | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Washington, Virology Research Clinic | Seattle | Washington | 98104 | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| Adverse Event |
|
| BG002 | Dose Regimen 3 | AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration |
| BG003 | Dose Regimen 4 | AIC316: 400 mg QWK, Oral administration |
| BG004 | Placebo | Matching placebo: Oral administration |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration |
| OG002 | Dose Regimen 3 | AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration |
| OG003 | Dose Regimen 4 | AIC316: 400 mg QWK, Oral administration |
| OG004 | Placebo | Matching placebo: Oral administration |
|
|
| 33 |
| 0 |
| 33 |
| 27 |
| 33 |
| EG001 | Dose Regimen 2 | AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration | 0 | 32 | 0 | 32 | 26 | 32 |
| EG002 | Dose Regimen 3 | AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration | 0 | 29 | 0 | 29 | 27 | 29 |
| EG003 | Dose Regimen 4 | AIC316: 400 mg QWK, Oral administration | 0 | 31 | 0 | 31 | 23 | 31 |
| EG004 | Placebo | Matching placebo: Oral administration | 0 | 30 | 0 | 30 | 23 | 30 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in the Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General Disorders and Administration Site Conditions | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Reproductive System and Breast Disorders | Reproductive system and breast disorders | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
|
| Pruritus Genital | Reproductive system and breast disorders | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood and Lymphatic System Disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
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