HSV-2 InfectionPhase 2NCT07912996
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
A Phase 2 study testing GS-1179, GS-1179 PTM and Valacyclovir in people with HSV-2 Infection, run by Gilead Sciences.
Trial summary
The goal of this clinical study is to compare the study drug GS-1179, versus valacyclovir (VACV) in herpes simplex virus type 2 (HSV-2) seropositive participants with recurrent genital herpes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HSV-2 Infection
- What is being tested?
- GS-1179, GS-1179 PTM and Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Individuals assigned male or female at birth, 18 years of age or older at screening, able to understand and give written informed consent and comply with treatment and follow up. Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must be nonpregnant, nonlactating, and agree to use protocol-specified method(s) of contraception.
- Individual is HSV-2 seropositive (or HSV-1 seropositive AND HSV-2 seropositive)
- Individual has a history of recurrent genital herpes for at least 1 year, with 4 to 9 clinical occurrences in the last year or, if currently on suppressive therapy, 4 to 9 occurrences a year prior to initiating suppressive therapy.
- Other than HSV infection, individual is in good health (as determined by the investigator). Medical history and physical examination should be without clinically significant abnormalities.
Who cannot join
- Individual has an acute episode of genital herpes during screening or on Day 1 prior to dosing.
- Individual has any other clinically significant medical, behavioral, mental condition, substance use disorder, or pharmacologic or surgical treatment that, in the opinion of the investigator or the sponsor, may interfere with efficacy or safety assessments, or the absorption, distribution, and/or elimination of the study drug, or make the individual unsuitable for study participation.
- Individual has a history of refractory or resistant HSV infection to any HSV-specific nucleoside analog including valacyclovir, acyclovir, famciclovir, penciclovir, ganciclovir, or valganciclovir.
- Individual has had treatment with any investigational or approved helicase-primase inhibitor (HPI) (including ABI-5366, ABI-1179, pritelivir, adibelivir [IM-250], amenamavir) or received an investigational HSV vaccine. However, individuals may be eligible if they participated in an investigational HPI study or an investigational HSV vaccine study but have sponsor documentation that they did not receive active product (eg, placebo recipients).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Active-Control, Parallel-Group Study to Evaluate the Safety and Efficacy of GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
The goal of this clinical study is to compare the study drug GS-1179, versus valacyclovir (VACV) in herpes simplex virus type 2 (HSV-2) seropositive participants with recurrent genital herpes.
The primary objective of this study are to evaluate the safety and tolerability of GS-1179 versus VACV and to evaluate the antiviral effect of GS-1179 versus VACV.
- Conditions
- HSV-2 Infection
- Being tested
- GS-1179, GS-1179 PTM, Valacyclovir, Valacyclovir PTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-1179Drug
Administered orally
GS-1179 PTMDrug
Administered orally
ValacyclovirDrug
Administered orally
Valacyclovir PTMDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| GS-1179 High Dose + VACV Placebo to Match (PTM) | Experimental | Participants will be randomized to receive a high-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days. Receives: Drug: GS-1179; Drug: Valacyclovir PTM |
| GS-1179 Low Dose + VACV Placebo to Match (PTM) | Experimental | Participants will be randomized to receive a low-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days. Receives: Drug: GS-1179; Drug: Valacyclovir PTM |
| VACV + GS-1179 PTM | Active comparator | Participants will be randomized to receive VACV once daily up to 92 days and GS-1179 PTM once weekly up to 85 days. Receives: Drug: GS-1179 PTM; Drug: Valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Adverse Events (AEs)
Measured: Enrollment up to 92 days
Percentage of Participants Experiencing Premature Study-Dug Discontinuation due to AEs
Measured: Enrollment up to 92 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Measured: First dose date up to 92 days
Herpes Simplex Virus Type 2 (HSV-2) Shedding Rate During the Swabbing Period
Measured: Day 8 to Day 38
Secondary outcomes (17)
Proportion of Participants Free of Genital Herpes Recurrences at Day 92
Measured: Day 92
Proportion of Participants Free of Genital Herpes Recurrences at Day 120
Measured: Day 120
Genital Herpes Lesion Rate During the Treatment Period
Measured: Up to 92 days
Genital Herpes Lesion Duration During the Treatment Period
Measured: Up to 92 days
Virologically Confirmed Genital Herpes Lesion Rate During the Treatment Period
Measured: Up to 92 days
Virologically Confirmed Genital Herpes Lesion Duration During the Treatment Period
Measured: Up to 92 days
Time to Suppression of HSV-2 Shedding
Measured: Up to 92 days
Number of HSV-2 Shedding Episodes During the Swabbing Period
Measured: Day 8 to Day 38
Duration of HSV-2 Shedding Episodes During the Swabbing Period
Measured: Day 8 to Day 38
Proportion of Participants With Subclinical HSV-2 Shedding During the Swabbing Period
Subclinical HSV-2 shedding is defined as swabs testing positive for HSV-2 DNA during the Swabbing Period that are not accompanied by lesions.
Measured: Day 8 to Day 38
HSV-2 DNA (Copies/mL) for Swab Samples that are Positive for HSV-2 DNA During the Swabbing Period
Measured: Day 8 to Day 38
HSV-2 DNA (Copies/mL) for Positive Swab Samples in the Absence of Lesions (Subclinical Shedding) During the Swabbing Period
Measured: Day 8 to Day 38
Proportion of Swab Samples With HSV-2 DNA > 4 log10 Copies/mL for Positive Swab Samples During the Swabbing Period
Measured: Day 8 to Day 38
Proportion of Swab Samples With HSV-2 DNA > 4 log10 Copies/mL for Positive Swab Samples in the Absence of Lesions (Subclinical Shedding) During the Swabbing Period
Measured: Day 8 to Day 38
Plasma Pharmacokinetic (PK) Parameters: Cmax of GS-1179
Cmax is defined as the maximum observed concentration of drug at steady state.
Measured: Day 1 up to 92 days
Plasma PK Parameters: AUCtau of GS-1179
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state.
Measured: Day 1 up to 92 days
Plasma PK Parameters: Ctrough of GS-1179
Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state.
Measured: Day 1 up to 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912996
- Sponsor's protocol ID
- GS-US-578-8029
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Active-Control, Parallel-Group Study to Evaluate the Safety and Efficacy of GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
- ClinicalTrials.gov ID
- NCT07912996
- Acronym / sponsor ID
- GS-US-578-8029
- Conditions
- HSV-2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to compare the study drug GS-1179, versus valacyclovir (VACV) in herpes simplex virus type 2 (HSV-2) seropositive participants with recurrent genital herpes.
The primary objective of this study are to evaluate the safety and tolerability of GS-1179 versus VACV and to evaluate the antiviral effect of GS-1179 versus VACV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GS-1179 High Dose + VACV Placebo to Match (PTM) | Experimental | Drug: GS-1179, Drug: Valacyclovir PTMParticipants will be randomized to receive a high-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days. |
| GS-1179 Low Dose + VACV Placebo to Match (PTM) | Experimental | Drug: GS-1179, Drug: Valacyclovir PTMParticipants will be randomized to receive a low-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days. |
| VACV + GS-1179 PTM | Active comparator | Drug: GS-1179 PTM, Drug: ValacyclovirParticipants will be randomized to receive VACV once daily up to 92 days and GS-1179 PTM once weekly up to 85 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals assigned male or female at birth, 18 years of age or older at screening, able to understand and give written informed consent and comply with treatment and follow up. Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must be nonpregnant, nonlactating, and agree to use protocol-specified method(s) of contraception.
- Individual is HSV-2 seropositive (or HSV-1 seropositive AND HSV-2 seropositive)
- Individual has a history of recurrent genital herpes for at least 1 year, with 4 to 9 clinical occurrences in the last year or, if currently on suppressive therapy, 4 to 9 occurrences a year prior to initiating suppressive therapy.
- Other than HSV infection, individual is in good health (as determined by the investigator). Medical history and physical examination should be without clinically significant abnormalities.
Key exclusion criteria (5 listed)
- Individual has an acute episode of genital herpes during screening or on Day 1 prior to dosing.
- Individual has any other clinically significant medical, behavioral, mental condition, substance use disorder, or pharmacologic or surgical treatment that, in the opinion of the investigator or the sponsor, may interfere with efficacy or safety assessments, or the absorption, distribution, and/or elimination of the study drug, or make the individual unsuitable for study participation.
- Individual has a history of refractory or resistant HSV infection to any HSV-specific nucleoside analog including valacyclovir, acyclovir, famciclovir, penciclovir, ganciclovir, or valganciclovir.
- Individual has had treatment with any investigational or approved helicase-primase inhibitor (HPI) (including ABI-5366, ABI-1179, pritelivir, adibelivir [IM-250], amenamavir) or received an investigational HSV vaccine. However, individuals may be eligible if they participated in an investigational HPI study or an investigational HSV vaccine study but have sponsor documentation that they did not receive active product (eg, placebo recipients).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| GS-1179Administered orally | Drug | GS-1179 High Dose + VACV Placebo to Match (PTM), GS-1179 Low Dose + VACV Placebo to Match (PTM) |
| GS-1179 PTMAdministered orally | Drug | VACV + GS-1179 PTM |
| ValacyclovirAdministered orally | Drug | VACV + GS-1179 PTM |
| Valacyclovir PTMAdministered orally | Drug | GS-1179 High Dose + VACV Placebo to Match (PTM), GS-1179 Low Dose + VACV Placebo to Match (PTM) |
Primary outcome
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: Enrollment up to 92 days
Percentage of Participants Experiencing Premature Study-Dug Discontinuation due to AEs
Time frame: Enrollment up to 92 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Time frame: First dose date up to 92 days
Herpes Simplex Virus Type 2 (HSV-2) Shedding Rate During the Swabbing Period
Time frame: Day 8 to Day 38
17 secondary outcomes
Proportion of Participants Free of Genital Herpes Recurrences at Day 92
Time frame: Day 92
Proportion of Participants Free of Genital Herpes Recurrences at Day 120
Time frame: Day 120
Genital Herpes Lesion Rate During the Treatment Period
Time frame: Up to 92 days
Genital Herpes Lesion Duration During the Treatment Period
Time frame: Up to 92 days
Virologically Confirmed Genital Herpes Lesion Rate During the Treatment Period
Time frame: Up to 92 days
Virologically Confirmed Genital Herpes Lesion Duration During the Treatment Period
Time frame: Up to 92 days
Time to Suppression of HSV-2 Shedding
Time frame: Up to 92 days
Number of HSV-2 Shedding Episodes During the Swabbing Period
Time frame: Day 8 to Day 38
Duration of HSV-2 Shedding Episodes During the Swabbing Period
Time frame: Day 8 to Day 38
Proportion of Participants With Subclinical HSV-2 Shedding During the Swabbing Period
Time frame: Day 8 to Day 38
HSV-2 DNA (Copies/mL) for Swab Samples that are Positive for HSV-2 DNA During the Swabbing Period
Time frame: Day 8 to Day 38
HSV-2 DNA (Copies/mL) for Positive Swab Samples in the Absence of Lesions (Subclinical Shedding) During the Swabbing Period
Time frame: Day 8 to Day 38
Proportion of Swab Samples With HSV-2 DNA > 4 log10 Copies/mL for Positive Swab Samples During the Swabbing Period
Time frame: Day 8 to Day 38
Proportion of Swab Samples With HSV-2 DNA > 4 log10 Copies/mL for Positive Swab Samples in the Absence of Lesions (Subclinical Shedding) During the Swabbing Period
Time frame: Day 8 to Day 38
Plasma Pharmacokinetic (PK) Parameters: Cmax of GS-1179
Time frame: Day 1 up to 92 days
Plasma PK Parameters: AUCtau of GS-1179
Time frame: Day 1 up to 92 days
Plasma PK Parameters: Ctrough of GS-1179
Time frame: Day 1 up to 92 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for HSV-2 Infection
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
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.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-1179, GS-1179 PTM and Valacyclovir in people with HSV-2 Infection, run by Gilead Sciences.
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 5 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Adverse Events (AEs) (time frame: Enrollment up to 92 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.