Trial Outcomes & Findings for Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2 (NCT NCT01047540)
NCT ID: NCT01047540
Last Updated: 2023-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
28 days
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Dose Regimen 1
AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
|
Dose Regimen 2
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
|
Dose Regimen 3
AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
|
Dose Regimen 4
AIC316: 400 mg QWK, Oral administration
|
Placebo
Matching placebo: Oral administration
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
29
|
31
|
30
|
|
Overall Study
Full Analysis Set
|
33
|
32
|
29
|
31
|
30
|
|
Overall Study
COMPLETED
|
29
|
32
|
26
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dose Regimen 1
AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
|
Dose Regimen 2
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
|
Dose Regimen 3
AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
|
Dose Regimen 4
AIC316: 400 mg QWK, Oral administration
|
Placebo
Matching placebo: Oral administration
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
Baseline characteristics by cohort
| Measure |
Dose Regimen 1
n=33 Participants
AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
|
Dose Regimen 2
n=32 Participants
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
|
Dose Regimen 3
n=29 Participants
AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
|
Dose Regimen 4
n=31 Participants
AIC316: 400 mg QWK, Oral administration
|
Placebo
n=30 Participants
Matching placebo: Oral administration
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 Years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
38.8 Years
STANDARD_DEVIATION 12.00 • n=7 Participants
|
41.6 Years
STANDARD_DEVIATION 12.47 • n=5 Participants
|
42.0 Years
STANDARD_DEVIATION 11.79 • n=4 Participants
|
43.1 Years
STANDARD_DEVIATION 10.81 • n=21 Participants
|
40.5 Years
STANDARD_DEVIATION 11.97 • n=10 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
104 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
116 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysSubjects 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.
Outcome measures
| Measure |
Dose Regimen 1
n=33 Participants
AIC316: Day 1 20 mg, Day 2-28, 5 mg QD, Oral administration
|
Dose Regimen 2
n=32 Participants
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
|
Dose Regimen 3
n=29 Participants
AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
|
Dose Regimen 4
n=31 Participants
AIC316: 400 mg QWK, Oral administration
|
Placebo
n=30 Participants
Matching placebo: Oral administration
|
|---|---|---|---|---|---|
|
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)
|
21.2 percentage of swab days
Standard Deviation 23.79
|
9.2 percentage of swab days
Standard Deviation 12.61
|
2.0 percentage of swab days
Standard Deviation 4.00
|
5.2 percentage of swab days
Standard Deviation 6.50
|
16.5 percentage of swab days
Standard Deviation 18.61
|
Adverse Events
Dose Regimen 1
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Dose Regimen 2
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Dose Regimen 3
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Dose Regimen 4
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Regimen 1
n=33 participants at risk
AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
|
Dose Regimen 2
n=32 participants at risk
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
|
Dose Regimen 3
n=29 participants at risk
AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
|
Dose Regimen 4
n=31 participants at risk
AIC316: 400 mg QWK, Oral administration
|
Placebo
n=30 participants at risk
Matching placebo: Oral administration
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
51.5%
17/33
|
40.6%
13/32
|
58.6%
17/29
|
48.4%
15/31
|
40.0%
12/30
|
|
Gastrointestinal disorders
Nausea
|
27.3%
9/33
|
15.6%
5/32
|
17.2%
5/29
|
29.0%
9/31
|
13.3%
4/30
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
3/33
|
9.4%
3/32
|
17.2%
5/29
|
12.9%
4/31
|
10.0%
3/30
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.1%
2/33
|
12.5%
4/32
|
13.8%
4/29
|
6.5%
2/31
|
10.0%
3/30
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33
|
3.1%
1/32
|
6.9%
2/29
|
12.9%
4/31
|
6.7%
2/30
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/33
|
12.5%
4/32
|
0.00%
0/29
|
0.00%
0/31
|
0.00%
0/30
|
|
Nervous system disorders
Nervous System Disorders
|
39.4%
13/33
|
46.9%
15/32
|
48.3%
14/29
|
51.6%
16/31
|
40.0%
12/30
|
|
Nervous system disorders
Headache
|
36.4%
12/33
|
43.8%
14/32
|
37.9%
11/29
|
45.2%
14/31
|
40.0%
12/30
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33
|
3.1%
1/32
|
17.2%
5/29
|
6.5%
2/31
|
3.3%
1/30
|
|
Infections and infestations
Infections and Infestations
|
36.4%
12/33
|
25.0%
8/32
|
27.6%
8/29
|
25.8%
8/31
|
33.3%
10/30
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
3/33
|
6.2%
2/32
|
3.4%
1/29
|
9.7%
3/31
|
3.3%
1/30
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
2/33
|
3.1%
1/32
|
3.4%
1/29
|
0.00%
0/31
|
10.0%
3/30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
30.3%
10/33
|
28.1%
9/32
|
24.1%
7/29
|
19.4%
6/31
|
36.7%
11/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33
|
15.6%
5/32
|
6.9%
2/29
|
3.2%
1/31
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.0%
1/33
|
6.2%
2/32
|
6.9%
2/29
|
3.2%
1/31
|
16.7%
5/30
|
|
Musculoskeletal and connective tissue disorders
Pain in the Extremity
|
6.1%
2/33
|
6.2%
2/32
|
6.9%
2/29
|
6.5%
2/31
|
10.0%
3/30
|
|
General disorders
General Disorders and Administration Site Conditions
|
21.2%
7/33
|
18.8%
6/32
|
27.6%
8/29
|
9.7%
3/31
|
26.7%
8/30
|
|
General disorders
Fatigue
|
12.1%
4/33
|
6.2%
2/32
|
17.2%
5/29
|
9.7%
3/31
|
16.7%
5/30
|
|
General disorders
Pyrexia
|
3.0%
1/33
|
3.1%
1/32
|
10.3%
3/29
|
3.2%
1/31
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
21.2%
7/33
|
12.5%
4/32
|
24.1%
7/29
|
16.1%
5/31
|
26.7%
8/30
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.1%
2/33
|
0.00%
0/32
|
6.9%
2/29
|
6.5%
2/31
|
13.3%
4/30
|
|
Reproductive system and breast disorders
Pruritus Genital
|
3.0%
1/33
|
0.00%
0/32
|
6.9%
2/29
|
3.2%
1/31
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
12.1%
4/33
|
12.5%
4/32
|
20.7%
6/29
|
22.6%
7/31
|
20.0%
6/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.0%
1/33
|
6.2%
2/32
|
13.8%
4/29
|
12.9%
4/31
|
10.0%
3/30
|
|
Psychiatric disorders
Psychiatric Disorders
|
9.1%
3/33
|
12.5%
4/32
|
17.2%
5/29
|
12.9%
4/31
|
10.0%
3/30
|
|
Psychiatric disorders
Insomnia
|
6.1%
2/33
|
9.4%
3/32
|
10.3%
3/29
|
6.5%
2/31
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
6.1%
2/33
|
18.8%
6/32
|
17.2%
5/29
|
22.6%
7/31
|
10.0%
3/30
|
|
Investigations
Investigations
|
3.0%
1/33
|
3.1%
1/32
|
13.8%
4/29
|
6.5%
2/31
|
16.7%
5/30
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
3.0%
1/33
|
3.1%
1/32
|
17.2%
5/29
|
6.5%
2/31
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
6.1%
2/33
|
3.1%
1/32
|
10.3%
3/29
|
3.2%
1/31
|
3.3%
1/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place