A Phase 2 interventional study of GS-1179 and GS-1179 PTM in HSV-2 Infection, sponsored by Gilead Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
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.
Gilead Sciences is the lead sponsor of 692 studies on the registry; 26 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: GS-1179 · Drug: Valacyclovir PTM
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.
Drug: GS-1179 · Drug: Valacyclovir PTM
Participants will be randomized to receive VACV once daily up to 92 days and GS-1179 PTM once weekly up to 85 days.
Drug: GS-1179 PTM · Drug: Valacyclovir
Administered orally
Administered orally
Administered orally
Administered orally
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
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
Subclinical HSV-2 shedding is defined as swabs testing positive for HSV-2 DNA during the Swabbing Period that are not accompanied by lesions.
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
Cmax is defined as the maximum observed concentration of drug at steady state.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 up to 92 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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