Table of Contents
- Trial overview
- CMV studies in pregnancy
- Generalized periodontitis study
- Other trials that list Valaciclovir
- Main outcomes measured
- Study status and phases
Trial overview
The trial record shows several interventional studies, which means researchers gave a treatment or compared treatments to see what happened.[1] Most of the studies are in Phase 2 or Phase 3, so they are testing Valaciclovir in real patient groups and looking at how well the study goals are met.[1]
The main areas studied are CMV infection in pregnancy and generalized periodontitis.[1] Two withdrawn trials also list Valaciclovir in other settings, but they are not the main focus of the available research record.[1]
CMV studies in pregnancy
Three authorised trials focus on CMV during pregnancy and the risk of passing infection to the baby.[1] One Phase 3 study, CYMEVAL III, compares letermovir against Valaciclovir in pregnant women carrying a CMV-infected fetus after a first-trimester maternal infection.[1]
In that study, the first step looks at how letermovir moves through the placenta and reaches the fetus, while the second step checks whether it leads to more newborns with a negative CMV PCR than Valaciclovir.[1] The main endpoint is a negative CMV PCR in neonatal blood on the first day of life, or in cord blood if the pregnancy is ended.[1]
Another Phase 2 study compares different doses of Valaciclovir in pregnant women with primary CMV infection.[1] Its goal is to see the effect on preventing transmission and treating infection inside the womb, while also checking safety.[1] The main outcome is whether CMV DNA is not found in the amniotic fluid of newborns in the compared groups.[1]
The third pregnancy study, Treat-CMV, is a Phase 3 trial in congenital CMV infection that aims to prevent vertical transmission, which means passing the virus from mother to baby during pregnancy.[1] The main endpoint is CMV PCR on amniotic fluid collected during amniocentesis at 20 weeks, with confirmation after birth using a urine sample.[1]
Generalized periodontitis study
One Phase 3 trial studies Valaciclovir in people with generalized periodontitis, which is advanced gum disease affecting many teeth.[1] The study compares standard non-surgical treatment, such as scaling and root surfacing, with the same treatment plus Valaciclovir or placebo.[1]
The trial includes patients with stage III or IV disease and grade A, B, or C, which describes how severe and how fast the disease may be progressing.[1] The main outcome is periodontal pocket depth, measured with a probe during the re-evaluation visit after treatment.[1]
Other trials that list Valaciclovir
Two withdrawn studies also mention Valaciclovir, but they are not focused on CMV or gum disease.[1] One Phase 3 trial in X-linked retinitis pigmentosa included Valaciclovir among many other medicines, and its main goal was to test eye-related treatment effects measured by MAIA microperimetry at Month 12.[1]
Another withdrawn Phase 2 study in people with end stage renal failure looked at OM336 and included Valaciclovir as part of the study treatment plan.[1] Its main goals were safety, tolerability, and changes in vPRA, a transplant-related immune measure.[1]
Main outcomes measured
The pregnancy studies mainly measure whether CMV can be detected or not in blood, amniotic fluid, or urine samples.[1] These tests help researchers see whether the treatment may reduce infection in the baby or lower the chance of transmission before birth.[1]
The gum disease study measures a clinical sign of healing or improvement: the depth of the pocket between the tooth and gum.[1] The withdrawn transplant study used safety and immune response measures instead of infection outcomes.[1]
Study status and phases
All of the Valaciclovir trials listed in the source data are either Authorised or Withdrawn.[1] The authorised studies include three Phase 3 pregnancy trials, one Phase 3 gum disease trial, and one Phase 2 pregnancy trial.[1]
The withdrawn studies show that Valaciclovir has also appeared in other research settings, but those trials did not continue to completion.[1] Together, the record shows that researchers are mainly interested in Valaciclovir for CMV-related pregnancy studies, with a separate study in periodontitis.[1]
