Trial Outcomes & Findings for Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes (NCT NCT01658826)
NCT ID: NCT01658826
Last Updated: 2023-04-21
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
28 days
Results posted on
2023-04-21
Participant Flow
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Period 1: First Intervention (28 Days)
STARTED
|
45
|
46
|
|
Period 1: First Intervention (28 Days)
COMPLETED
|
38
|
36
|
|
Period 1: First Intervention (28 Days)
NOT COMPLETED
|
7
|
10
|
|
Washout Period: 28 Days
STARTED
|
38
|
36
|
|
Washout Period: 28 Days
COMPLETED
|
32
|
32
|
|
Washout Period: 28 Days
NOT COMPLETED
|
6
|
4
|
|
Period 2: Second Intervention (28 Days)
STARTED
|
32
|
32
|
|
Period 2: Second Intervention (28 Days)
COMPLETED
|
29
|
27
|
|
Period 2: Second Intervention (28 Days)
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Period 1: First Intervention (28 Days)
Withdrawal by Subject
|
1
|
0
|
|
Period 1: First Intervention (28 Days)
Adverse Event
|
1
|
2
|
|
Period 1: First Intervention (28 Days)
Termination of the Study by the Investigator or Sponsor
|
5
|
6
|
|
Period 1: First Intervention (28 Days)
Protocol Violation
|
0
|
1
|
|
Period 1: First Intervention (28 Days)
Patient was non-compliant with study medication, swabbing and maintaining diary
|
0
|
1
|
|
Washout Period: 28 Days
Withdrawal by Subject
|
1
|
1
|
|
Washout Period: 28 Days
Termination of the Study by the Investigator or Sponsor
|
5
|
3
|
|
Period 2: Second Intervention (28 Days)
Withdrawal by Subject
|
0
|
1
|
|
Period 2: Second Intervention (28 Days)
Termination of the Study by the Investigator or Sponsor
|
3
|
4
|
Baseline Characteristics
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Baseline characteristics by cohort
| Measure |
AIC316, Then Valacyclovir
n=45 Participants
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
n=46 Participants
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.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 Years
STANDARD_DEVIATION 13.22 • n=93 Participants
|
45.5 Years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
45.4 Years
STANDARD_DEVIATION 12.26 • n=27 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: 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).
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.
Outcome measures
| Measure |
AIC316
n=76 Participants
Participants who received AIC316 100 mg once daily in either the first 28 days or last 28 days of the study.
|
Valacyclovir
n=76 Participants
Participants who received Valacyclovir 500 mg once daily in either the first 28 days or last 28 days of the study.
|
|---|---|---|
|
Within-subject Genital HSV Mucocutaneous Shedding Rate
|
2.3 percentage of positive swaps per subject
Standard Deviation 5.2
|
4.9 percentage of positive swaps per subject
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
AIC316
n=76 Participants
Participants who received AIC316 100 mg once daily in either the first 28 days or last 28 days of the study.
|
Valacyclovir
n=76 Participants
Participants who received Valacyclovir 500 mg once daily in either the first 28 days or last 28 days of the study.
|
|---|---|---|
|
Overall Shedding Rate
|
2.4 percentage of positive swabs
|
5.2 percentage of positive swabs
|
Adverse Events
AIC316
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Valacyclovir
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AIC316
n=77 participants at risk
Participants who received AIC316 100 mg once daily in either the first 28 days or last 28 days of the study.
|
Valacyclovir
n=78 participants at risk
Participants who received Valacyclovir 500 mg once daily in either the first 28 days or last 28 days of the study.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
11/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
10.3%
8/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.9%
3/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Infections and infestations
Tooth infection
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
1.3%
1/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Infections and infestations
Vaginitis bacteria
|
1.3%
1/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Infections and infestations
Sinusitis
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
0.00%
0/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Nervous system disorders
Headache
|
15.6%
12/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
17.9%
14/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Nervous system disorders
Dizziness
|
3.9%
3/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
5.1%
4/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Nausea
|
3.9%
3/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
5.1%
4/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Diarrhea
|
5.2%
4/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.3%
1/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
1.3%
1/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
1/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
0.00%
0/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
General disorders
Fatigue
|
3.9%
3/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
6.4%
5/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
General disorders
Chills
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
5.1%
4/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
1/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Psychiatric disorders
Anxiety
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
3.8%
3/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
1.3%
1/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
2/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
1.3%
1/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
|
Vascular disorders
Flushing
|
0.00%
0/77 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
2.6%
2/78 • 28 days for each intervention
AE reporting is based on the safety set versus the full analysis set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place