Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
28 oktober 2026 uppdaterad av: Gilead Sciences
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
300
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Key Inclusion Criteria:
- 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:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: GS-1179 High Dose + VACV Placebo to Match (PTM)
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. |
Administered orally Administered orally |
|
Experimentell: GS-1179 Low Dose + VACV Placebo to Match (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. |
Administered orally Administered orally |
|
Aktiv komparator: VACV + GS-1179 PTM
Participants will be randomized to receive VACV once daily up to 92 days and GS-1179 PTM once weekly up to 85 days. |
Administered orally Administered orally |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
Tidsram: Enrollment up to 92 days
|
Enrollment up to 92 days
|
|
Percentage of Participants Experiencing Premature Study-Dug Discontinuation due to AEs
Tidsram: Enrollment up to 92 days
|
Enrollment up to 92 days
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Tidsram: First dose date up to 92 days
|
First dose date up to 92 days
|
|
Herpes Simplex Virus Type 2 (HSV-2) Shedding Rate During the Swabbing Period
Tidsram: Day 8 to Day 38
|
Day 8 to Day 38
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants Free of Genital Herpes Recurrences at Day 92
Tidsram: Day 92
|
Day 92
|
|
|
Proportion of Participants Free of Genital Herpes Recurrences at Day 120
Tidsram: Day 120
|
Day 120
|
|
|
Genital Herpes Lesion Rate During the Treatment Period
Tidsram: Up to 92 days
|
Up to 92 days
|
|
|
Genital Herpes Lesion Duration During the Treatment Period
Tidsram: Up to 92 days
|
Up to 92 days
|
|
|
Virologically Confirmed Genital Herpes Lesion Rate During the Treatment Period
Tidsram: Up to 92 days
|
Up to 92 days
|
|
|
Virologically Confirmed Genital Herpes Lesion Duration During the Treatment Period
Tidsram: Up to 92 days
|
Up to 92 days
|
|
|
Time to Suppression of HSV-2 Shedding
Tidsram: Up to 92 days
|
Up to 92 days
|
|
|
Number of HSV-2 Shedding Episodes During the Swabbing Period
Tidsram: Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Duration of HSV-2 Shedding Episodes During the Swabbing Period
Tidsram: Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Proportion of Participants With Subclinical HSV-2 Shedding During the Swabbing Period
Tidsram: Day 8 to Day 38
|
Subclinical HSV-2 shedding is defined as swabs testing positive for HSV-2 DNA during the Swabbing Period that are not accompanied by lesions. |
Day 8 to Day 38
|
|
HSV-2 DNA (Copies/mL) for Swab Samples that are Positive for HSV-2 DNA During the Swabbing Period
Tidsram: Day 8 to Day 38
|
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
Tidsram: Day 8 to Day 38
|
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
Tidsram: Day 8 to Day 38
|
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
Tidsram: Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Plasma Pharmacokinetic (PK) Parameters: Cmax of GS-1179
Tidsram: Day 1 up to 92 days
|
Cmax is defined as the maximum observed concentration of drug at steady state. |
Day 1 up to 92 days
|
|
Plasma PK Parameters: AUCtau of GS-1179
Tidsram: Day 1 up to 92 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state. |
Day 1 up to 92 days
|
|
Plasma PK Parameters: Ctrough of GS-1179
Tidsram: Day 1 up to 92 days
|
Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state. |
Day 1 up to 92 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Gilead Study Director, Gilead Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 november 2026
Primärt slutförande (Beräknad)
1 november 2027
Avslutad studie (Beräknad)
1 november 2027
Studieregistreringsdatum
Först inskickad
28 oktober 2026
Först inskickad som uppfyllde QC-kriterierna
28 oktober 2026
Första postat (Faktisk)
3 november 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 oktober 2026
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GS-US-578-8029
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
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Nej
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