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Home › Conditions › Genital Herpes

Genital Herpes

Part of Herpesviridae Infections

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Genital Herpes

10 trials tracked for Genital Herpes: 7 in phase 3 or 4 and 2 with published results. The most-cited published study has 126 citations.

10Trials tracked
7Phase 3 & 4
0Recruiting
2With published results
Phase distribution
Phase 4 5 Phase 3 2 Phase 2 1 Other / NA 2
  1. Phase 4 Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 Completed · 126 cited
  2. Phase 4 A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation Completed · 126 cited
  3. Phase 4 Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV Completed
  4. Phase 4 Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients Completed
  5. Phase 4 Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 Completed
  6. Phase 3 Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes Completed
Show 4 more trials
  1. Phase 3 Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes Completed
  2. Phase 2 A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes Completed
  3. N/A GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women Completed
  4. N/A The VIBLOK SAfety and perFormancE Trial Completed

Showing the 10 most-cited and recently-updated of 10 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Genital Herpes: what the trials found

A phase 4 trial found that suppressive acyclovir significantly reduced HSV-2 genital shedding compared to no medication in both HIV-seronegative and HIV-seropositive individuals (per-day shedding rate: 24 vs. 3; p<0.001) 2. High-dose valacyclovir also significantly reduced shedding compared to once-daily valacyclovir (per-day shedding rate: 5 vs. 3; p<0.001) 3. However, high-dose acyclovir did not significantly reduce shedding compared to once-daily valacyclovir (per-day shedding rate: 4 vs. 4; p=0.052) 4. In a separate trial, valacyclovir 1 g twice daily significantly reduced HIV-1 RNA plasma levels compared to acyclovir 400 mg twice daily (4.08 vs. 3.68 log10 copies/mL; p<0.001), but no significant differences were observed in genital HSV shedding rate (8.2% vs. 7.8%; p=0.78) or percentage of days with genital herpes lesions (4.0% vs. 1.0%; p=0.16) 5.

In trials of famciclovir for genital herpes, one phase 4 trial found no significant difference in time to healing of non-aborted lesions compared to placebo (5.38 vs. 4.79 days; p=0.4161) and similar percentages of participants with aborted and non-aborted lesions (24.4% vs. 20.4% aborted; 75.6% vs. 79.6% non-aborted) 6. A phase 3 trial reported that 32.7% of participants on famciclovir had aborted lesions versus 33.6% on placebo 8. Another phase 3 trial (N=150) also evaluated famciclovir but no specific outcome data were provided 7.

Recent results — preliminary, needs further review

  • A phase 2 trial of mRNA-1608 (N=303) reported the number of genital herpes recurrence episodes per participant from 14 days after the second injection to 6 months: 1.4, 1.2, 1.3, and 1.0 across dose groups; and to 12 months: 2.8, 2.3, 2.5, and 1.8. Change from baseline in lesion rate (percentage of days with lesions) at 2 months after second injection was -7.75, -5.89, -10.70, and -5.84 1. These findings are recent and not yet corroborated.

For the clinician treating this condition

  • Suppressive acyclovir and high-dose valacyclovir significantly reduce HSV-2 genital shedding, but high-dose acyclovir was not superior to once-daily valacyclovir in reducing shedding.
  • Valacyclovir 1 g twice daily reduces HIV-1 RNA plasma levels more than acyclovir 400 mg twice daily, but does not significantly affect genital HSV shedding or lesion days.
  • Famciclovir did not show significant benefit over placebo in healing time or lesion abortion rates in the trials reviewed.

AI synthesis of 8 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Meta-analysis finds topical propolis/honey associated with faster herpes lesion resolution than acyclovir
Infectious Disease Meta-analysis
Meta-analysis finds topical propolis/honey associated with faster herpes lesion resolution than acyclovir Topical propolis and honey may help heal herpes lesions faster than acyclovir cream
A meta-analysis of 7 studies compared topical propolis and/or honey to 5% topical acyclovir for labial and genital herpes lesions.
Using natural propolis or honey on herpes sores healed lesions nearly two days faster and cut pain compared to standard acyclovir cream.
Apr 6, 2026

Research across Herpesviridae Infections

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This meta-analysis of 19 reports estimates a 32.5% overall seroprevalence of TORCH infections among pregnant women and infants in Malaysia, …
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FDA approves new over-the-counter drug Abreva to shorten cold sore healing time and ease painful symptoms like tingling and itching.
FDA Apr 17, 2026
Acyclovir treatment for HSV in febrile hospitalized children at Jinan Children's Hospital
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Acyclovir treatment for HSV in febrile hospitalized children at Jinan Children's Hospital The hidden troublemaker
This retrospective cohort study evaluated 100 febrile hospitalized children at Jinan Children's Hospital.
Finding a second germ alongside Herpes Simplex Virus in sick children explains why some stay hospitalized longer than expected.
Frontiers Apr 16, 2026
Global neonatal HSV incidence 8.2 per 100k births, rising 3.5% annually; nHSV-1 proportion increasing
Pediatrics Meta-analysis
Global neonatal HSV incidence 8.2 per 100k births, rising 3.5% annually; nHSV-1 proportion increasing A dangerous virus is affecting more newborns worldwide, with cases rising each year
A systematic review and meta-analysis found the global pooled incidence of neonatal herpes simplex virus (nHSV) is 8.2 per 100,000 live birt…
A dangerous newborn infection is rising worldwide, with cases increasing by 3.5% each year and highest rates now seen in the Americas.
Mar 30, 2026