In short
Clinical trials investigating Valaciclovir are studying how it may help in different health problems, mainly CMV infection in pregnancy and generalized periodontitis. These studies look at outcomes such as infection control, transmission rates, and treatment response in specific patient groups. Most trials are interventional and are in Phase 2 or Phase 3.
Key points
- Clinical trials of Valaciclovir are mainly focused on CMV infection in pregnancy, including prevention of mother-to-baby transmission and treatment of congenital CMV-related problems. Another Phase 3 study is testing it in generalized periodontitis to see whether it improves gum disease outcomes after standard cleaning and root treatment. The trial data also include a Phase 2 study in pregnant women with primary CMV infection that compares dose-related effects on safety and efficacy. Most studies are interventional and involve pregnant women or other specific patient groups. A few withdrawn trials also list Valaciclovir in unrelated settings, such as eye disease and transplant preparation. The main outcomes are lab tests for CMV and clinical measures like periodontal pocket depth.
Trial overview
The trial record shows several interventional studies, which means researchers gave a treatment or compared treatments to see what happened. 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.
The main areas studied are CMV infection in pregnancy and generalized periodontitis. Two withdrawn trials also list Valaciclovir in other settings, but they are not the main focus of the available research record.
CMV studies in pregnancy
Three authorised trials focus on CMV during pregnancy and the risk of passing infection to the baby. One Phase 3 study, CYMEVAL III, compares letermovir against Valaciclovir in pregnant women carrying a CMV-infected fetus after a first-trimester maternal infection.
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. 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.
Another Phase 2 study compares different doses of Valaciclovir in pregnant women with primary CMV infection. Its goal is to see the effect on preventing transmission and treating infection inside the womb, while also checking safety. The main outcome is whether CMV DNA is not found in the amniotic fluid of newborns in the compared groups.
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. The main endpoint is CMV PCR on amniotic fluid collected during amniocentesis at 20 weeks, with confirmation after birth using a urine sample.
Generalized periodontitis study
One Phase 3 trial studies Valaciclovir in people with generalized periodontitis, which is advanced gum disease affecting many teeth. The study compares standard non-surgical treatment, such as scaling and root surfacing, with the same treatment plus Valaciclovir or placebo.
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. The main outcome is periodontal pocket depth, measured with a probe during the re-evaluation visit after treatment.
Other trials that list Valaciclovir
Two withdrawn studies also mention Valaciclovir, but they are not focused on CMV or gum disease. 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.
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. Its main goals were safety, tolerability, and changes in vPRA, a transplant-related immune measure.
Main outcomes measured
The pregnancy studies mainly measure whether CMV can be detected or not in blood, amniotic fluid, or urine samples. These tests help researchers see whether the treatment may reduce infection in the baby or lower the chance of transmission before birth.
The gum disease study measures a clinical sign of healing or improvement: the depth of the pocket between the tooth and gum. The withdrawn transplant study used safety and immune response measures instead of infection outcomes.
Study status and phases
All of the Valaciclovir trials listed in the source data are either Authorised or Withdrawn. The authorised studies include three Phase 3 pregnancy trials, one Phase 3 gum disease trial, and one Phase 2 pregnancy trial.
The withdrawn studies show that Valaciclovir has also appeared in other research settings, but those trials did not continue to completion. Together, the record shows that researchers are mainly interested in Valaciclovir for CMV-related pregnancy studies, with a separate study in periodontitis.