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VALACICLOVIR HYDROCHLORIDE

Clinical trials are investigating VALACICLOVIR HYDROCHLORIDE in people with HSV-2 meningitis. These studies aim to see whether treatment helps improve outcomes and how it compares with placebo. The main focus is on safety and effectiveness in adults with this infection.

Table of Contents

Trial overview

The provided trial data include one interventional study of VALACICLOVIR HYDROCHLORIDE for people with HSV-2 meningitis.[1] The study is titled “Aciclovir for HSV-2 MENingitis: A double-blinded randomised controlled trial (AMEN),” and it is authorised.[1] Its brief summary says the researchers want to see whether active treatment with (val)acyclovir is better than placebo for viral meningitis.[1]

Study design and phase

This is a Phase 3 trial, which means it is a later-stage study meant to test how well the treatment works in a patient group.[1] It is a randomised controlled trial, so participants are assigned by chance to different study groups.[1] The study is also double-blinded, which means the patient and the study team do not know who receives active treatment or placebo.[1]

Who is being studied

The target condition in this trial is HSV-2 meningitis.[1] The source data do not list all inclusion or exclusion rules, but the study is clearly aimed at patients with this diagnosis.[1] The planned enrollment is 150 participants, which gives an idea of the study size.[1]

What the trial measures

The primary outcome is the proportion of patients with a Total Morbidity Score (TMS) greater than 6 at 7 days after randomisation.[1] In simple terms, the researchers are checking how many patients still have a higher illness burden one week after the study starts.[1] This endpoint helps show whether the treatment leads to better short-term recovery compared with placebo.[1]

Placebo and blinding

The interventions listed include active intravenous aciclovir, oral VALACICLOVIR HYDROCHLORIDE, and matching placebo products.[1] The placebo tablets and placebo intravenous treatment are made to look like the active products, which helps keep the comparison fair.[1] Because the study is double-blinded, the results are less likely to be influenced by expectations from patients or researchers.[1]

Trial summary

In the available data, VALACICLOVIR HYDROCHLORIDE is being studied in one Phase 3 trial for HSV-2 meningitis.[1] The study asks whether active treatment is superior to placebo and uses a short-term clinical score as the main outcome.[1] The trial is authorised, randomised, and double-blinded, with 150 planned participants.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05452928 Phase 3 HSV-2 meningitis Authorised 150

FAQ

  • What is being studied in trials of VALACICLOVIR HYDROCHLORIDE? The trial is studying whether active treatment with (val)acyclovir is better than placebo for viral meningitis caused by HSV-2. It looks at patient recovery after randomisation.
  • Who can take part in these trials? The trial targets people with HSV-2 meningitis. The source data does not list all exact entry rules, but the study is designed for patients with this diagnosis.
  • What phase is the VALACICLOVIR HYDROCHLORIDE trial? The study is a Phase 3 trial. Phase 3 trials usually test how well a treatment works in a larger group of patients.
  • What is the main outcome being measured? The main outcome is the proportion of patients with a Total Morbidity Score (TMS) greater than 6 at 7 days after randomisation. This measures how many patients still have a higher symptom burden after treatment.
  • Is the trial using a placebo? Yes. The study is double-blinded and randomised, and it uses placebo tablets and placebo intravenous treatment. Double-blinded means neither the patient nor the study team knows who gets the active treatment.

Ongoing Clinical Trials on VALACICLOVIR HYDROCHLORIDE

  • Study on Aciclovir and Valaciclovir for Treating HSV-2 Meningitis in Adults

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • HSV-2 meningitis: A type of meningitis caused by herpes simplex virus type 2. Meningitis means inflammation of the lining around the brain and spinal cord.
  • Randomised: Patients are placed into treatment groups by chance, not by choice. This helps make the comparison fair.
  • Double-blinded: Neither the patient nor the study team knows which treatment is given. This helps reduce bias.
  • Placebo: A treatment that looks like the real study drug but has no active medicine. It is used for comparison.
  • Phase 3: A later stage of clinical research that tests how well a treatment works in a larger group of people.
  • Interventional study: A study where researchers give a treatment or procedure and then measure the results.
  • Enrollment: The number of people planned to join the study.
  • Primary outcome: The main result the researchers want to measure to answer the study question.
  • Total Morbidity Score (TMS): A score used in the study to measure how much illness or symptom burden a patient has.
  • Randomisation: The process of assigning participants to study groups by chance.

References