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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01047540
Enrollment
156
Registered
2010-01-13
Start date
2010-03-31
Completion date
2011-03-31
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HSV-2

Brief summary

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

Interventions

DRUGAIC316

Oral administration

DRUGPlacebo

Oral administration

Sponsors

FHI 360
CollaboratorOTHER
AiCuris Anti-infective Cures AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Dose Regimen 1
AIC316: Day 1 20 mg, Day 2-28 5 mg QD, Oral administration
33
Dose Regimen 2
AIC316: Day 1 100 mg, Day 2-28 25 mg QD, Oral administration
32
Dose Regimen 3
AIC316: Day 1 300 mg, Day 2-28 75 mg QD, Oral administration
29
Dose Regimen 4
AIC316: 400 mg QWK, Oral administration
31
Placebo
Matching placebo: Oral administration
30
Total155

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyAdverse Event10000
Overall StudyLost to Follow-up10000
Overall StudyPregnancy10000
Overall StudyProtocol Violation10000
Overall StudyWithdrawal by Subject10301

Baseline characteristics

CharacteristicDose Regimen 1TotalPlaceboDose Regimen 4Dose Regimen 3Dose Regimen 2
Age, Continuous37.7 Years
STANDARD_DEVIATION 12.56
40.5 Years
STANDARD_DEVIATION 11.97
43.1 Years
STANDARD_DEVIATION 10.81
42.0 Years
STANDARD_DEVIATION 11.79
41.6 Years
STANDARD_DEVIATION 12.47
38.8 Years
STANDARD_DEVIATION 12
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants29 Participants7 Participants5 Participants4 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants8 Participants1 Participants2 Participants5 Participants0 Participants
Race (NIH/OMB)
White
25 Participants116 Participants21 Participants23 Participants20 Participants27 Participants
Sex: Female, Male
Female
22 Participants104 Participants21 Participants20 Participants20 Participants21 Participants
Sex: Female, Male
Male
11 Participants51 Participants9 Participants11 Participants9 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 320 / 290 / 310 / 30
other
Total, other adverse events
27 / 3326 / 3227 / 2923 / 3123 / 30
serious
Total, serious adverse events
0 / 330 / 320 / 290 / 310 / 30

Outcome results

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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
Dose Regimen 1Efficacy 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 daysStandard Deviation 23.79
Dose Regimen 2Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)9.2 percentage of swab daysStandard Deviation 12.61
Dose Regimen 3Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)2.0 percentage of swab daysStandard Deviation 4
Dose Regimen 4Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)5.2 percentage of swab daysStandard Deviation 6.5
PlaceboEfficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)16.5 percentage of swab daysStandard Deviation 18.61

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026