HSV-2Phase 2NCT01047540
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
A Phase 2 study testing AIC316 in people with HSV-2, run by AiCuris Anti-infective Cures AG at 6 sites in United States.
Trial summary
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HSV-2
- What is being tested?
- AIC316
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Texas Health Science Centre, Center for Clincial Studies
Houston, Texas, 77030
Indiana University School of Medicine, Office for Research
Indianapolis, Indiana, 46202
Cetero Research Miami Gardens
Miami, Florida, 33169
Westover Heights Clinic
Portland, Oregon, 97210
University of Utah
Salt Lake City, Utah, 84132
University of Washington, Virology Research Clinic
Seattle, Washington, 98104
About this study
Official title: 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
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
- Conditions
- HSV-2
- Being tested
- AIC316, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIC316Drug
Also called pritelivir
Oral administration
AIC316Drug
Also called pritelivir
Oral administration
AIC316Drug
Also called pritelivir
Oral administration
AIC316Drug
Also called pritelivir
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dose regimen 1 | Experimental | Not described Receives: Drug: AIC316 |
| Dose regimen 2 | Experimental | Not described Receives: Drug: AIC316 |
| Dose regimen 3 | Experimental | Not described Receives: Drug: AIC316 |
| Dose regimen 4 | Experimental | Not described Receives: Drug: AIC316 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HSV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiCuris Anti-infective Cures AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FHI 360
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047540
- Sponsor's protocol ID
- AIC316-01-II-01
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2010
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24428466
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01047540
- Acronym / sponsor ID
- AIC316-01-II-01
- Conditions
- HSV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AiCuris Anti-infective Cures AGIndustry (pharma, biotech, devices)
- Collaborators
- FHI 360
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 4 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose regimen 1 | Experimental | Drug: AIC316 |
| Dose regimen 2 | Experimental | Drug: AIC316 |
| Dose regimen 3 | Experimental | Drug: AIC316 |
| Dose regimen 4 | Experimental | Drug: AIC316 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIC316Also: pritelivirOral administration | Drug | Dose regimen 1 |
| AIC316Also: pritelivirOral administration | Drug | Dose regimen 2 |
| AIC316Also: pritelivirOral administration | Drug | Dose regimen 3 |
| AIC316Also: pritelivirOral administration | Drug | Dose regimen 4 |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)
Time frame: 28 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24428466Wald 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIC316 in people with HSV-2, run by AiCuris Anti-infective Cures AG at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.