Table of Contents

• Clinical trials overview
• Neurologic and intensive care studies
• Skin and mucosal herpes studies
• Oncology study with Aciclovir
• Other trial including Aciclovir
• Key outcomes and study designs
• What the trials mean for participants

Clinical trials overview

The trial data show that Aciclovir is being studied in several different settings, including nervous system infection, intensive care, skin herpes, and cancer care.^{[1][2][3][4][5]}

Most studies are Phase 3 trials, which usually compare treatments in larger groups, and one study is Phase 2.^{[1][2][3][4][5]}

The studies are mostly interventional, meaning the researchers give a treatment and then measure what happens.^{[1][2][3][4][5]}

Neurologic and intensive care studies

One authorised Phase 3 study is testing whether active treatment with (val)acyclovir is better than placebo for HSV-2 meningitis, which is inflammation of the covering of the brain and spinal cord caused by herpes simplex virus type 2.^[1]

This study is double-blinded and randomised, so the treatment groups are assigned by chance and neither the participants nor the study team know who gets the active treatment or the placebo during the trial.^[1]

The main outcome is the proportion of patients with a Total Morbidity Score above 6 at 7 days after randomisation.^[1]

Another Phase 3 study is in ventilated intensive care patients with pneumonia and detection of herpes simplex virus type 1 in bronchoalveolar lavage, a lung fluid sample used to look for infection.^[2]

That study is measuring 30-day mortality, so it focuses on whether patients survive during the first month after treatment begins.^[2]

A third Phase 3 study is in ICU patients on invasive mechanical ventilation who have HSV throat reactivation and one or no organ failures.^[3]

Its main endpoint is mortality at day 60 after randomisation, which means the study is looking at survival two months after treatment assignment.^[3]

Skin and mucosal herpes studies

One Phase 3 study is testing Lipovir® Gel, which contains Aciclovir 5%, against Zovirax® Cream, which also contains Aciclovir 5%, and against placebo in people with recurrent herpes labialis, or repeated cold sores.^[4]

The study is looking at duration of episode, which means how long a cold sore outbreak lasts from the start of treatment until healing or return to normal skin and symptoms stop.^[4]

This design helps researchers compare one Aciclovir product with another Aciclovir product and with no active treatment.^[4]

Oncology study with Aciclovir

One Phase 2 study in adults with very high-risk T-cell acute lymphoblastic leukemia includes Aciclovir as part of a larger treatment program with many other medicines.^[5]

The main outcome is MRD negativity after induction, meaning no minimal residual disease is found at a very low test level after the first treatment cycle.^[5]

This study is not testing Aciclovir alone, so the result reflects the full treatment plan rather than Aciclovir by itself.^[5]

Other trial including Aciclovir

One withdrawn Phase 3 trial in X-linked retinitis pigmentosa listed Aciclovir among several supportive medicines used around a subretinal gene therapy study.^[6]

The main efficacy endpoint in Europe was the change in mean sensitivity across the whole grid at Month 12, measured by MAIA microperimetry, a test of how well the retina detects light in different spots.^[6]

Because the study is withdrawn, it did not continue as planned.^[6]

Key outcomes and study designs

The trials use different endpoints depending on the disease being studied, such as survival, symptom duration, and treatment response.^{[1][2][3][4][5][6]}

Some studies compare Aciclovir with placebo, while others compare it with another active treatment or use it as part of a broader treatment regimen.^[1][4][5]

The enrollment sizes range from small studies with 31 participants to larger studies with 866 participants, showing that the research includes both focused and broad patient groups.^[5][7]

What the trials mean for participants

These studies are aimed at people with specific conditions, not at the general population.^{[1][2][3][4][5]}

Eligibility depends on the condition, such as HSV-2 meningitis, ICU ventilation with HSV findings, recurrent cold sores, or very high-risk leukemia.^{[1][2][3][4][5]}

From the trial data, the main goal is to learn whether Aciclovir-based strategies improve important outcomes for each patient group, such as recovery, survival, or episode length.^{[1][2][3][4][5]}