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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIC316, Then Valacyclovir | Experimental | Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days. |
|
| Valacyclovir, Then AIC316 | Active Comparator | Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIC316 | Drug | 100 mg oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Within-subject Genital HSV Mucocutaneous Shedding Rate | Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate. | 28 days |
| Overall Shedding Rate | Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine, IU Infectious Diseases Research | Indianapolis | Indiana | 46202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27997653 | Derived | Wald A, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Fife K, Selke S, Huang ML, Stobernack HP, Zimmermann H, Corey L, Birkmann A, Ruebsamen-Schaeff H. Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences: A Randomized Clinical Trial. JAMA. 2016 Dec 20;316(23):2495-2503. doi: 10.1001/jama.2016.18189. |
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150 subjects were screened, 59 were screen failures (did not meet study eligibility requirements: 35, withdrawal of Consent 1, Lost to Follow-up 1, Other 22). 91 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIC316, Then Valacyclovir | Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days |
| FG001 | Valacyclovir, Then AIC316 | Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention (28 Days) |
|
| |||||||||||||||||||||
| Washout Period: 28 Days |
| ||||||||||||||||||||||
| Period 2: Second Intervention (28 Days) |
|
All randomized subjects assign to a treatment sequence.
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| ID | Title | Description |
|---|---|---|
| BG000 | AIC316, Then Valacyclovir | Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days. |
| BG001 | Valacyclovir, Then AIC316 |
| 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 | Within-subject Genital HSV Mucocutaneous Shedding Rate | Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate. | All subjects who received at least one dose of trial medication and provided at least 1 analyzable genital-perianal swab (not including the training swab) during the treatment period were included in the efficacy analysis (Full Analysis Set). | Posted | Mean | Standard Deviation | percentage of positive swaps per subject | 28 days |
|
28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
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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 | AIC316 | Participants who received AIC316 100 mg once daily in either the first 28 days or last 28 days of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | 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 |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C453221 | pritelivir |
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| Valacyclovir | Drug | 500 mg oral administration |
|
| 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 Washington, Virology Research Clinic | Seattle | Washington | 98104 | United States |
| Termination of the Study by the Investigator or Sponsor |
|
| Protocol Violation |
|
| Patient was non-compliant with study medication, swabbing and maintaining diary |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| AIC316 |
Participants who received AIC316 100 mg once daily in either the first 28 days or last 28 days of the study. |
| OG001 | Valacyclovir | Participants who received Valacyclovir 500 mg once daily in either the first 28 days or last 28 days of the study. |
|
|
|
| Primary | Overall Shedding Rate | Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group. | Full Analysis Set - defined as all randomized subjects who took trial medication at least once and provided at least 1 analyzable genital-perianal swab (not including the training swab) during the treatment period. | Posted | Number | percentage of positive swabs | 28 days |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 48 |
| 77 |
| EG001 | Valacyclovir | Participants who received Valacyclovir 500 mg once daily in either the first 28 days or last 28 days of the study. | 0 | 78 | 0 | 78 | 54 | 78 |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Vaginitis bacteria | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
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| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |