Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
valacyclovir · 1 trial · 2 indications
Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum |
| 2 | PLACEBO_COMPARATOR | oral placebo twice daily from 34 weeks gestation to 1 year postpartum |
| Name | Type | Description |
|---|---|---|
| valacyclovir | DRUG | 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum |
| placebo | DRUG | oral placebo twice daily from 34 weeks gestation to 1 year postpartum |
Inclusion Criteria: * HIV-1 seropositive * HSV-2 seropositive * Plans to deliver in Nairobi * Resides and plans to remain in Nairobi for 12 months postpartum * 18 years of age or older * CD4 count\>250 cells/μl Exclusion Criteria: * indication for highly active antiretroviral therapy (e.g., WHO s...
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Valacyclovir is an investigational small molecule being studied for use in HIV Infections, specifically to suppress HSV-2 and reduce maternal HIV-1 RNA levels during pregnancy and breastfeeding. It is in Phase 2 clinical development and is not yet approved for this indication.
Valacyclovir targets herpes simplex virus (HSV), including HSV-2. In the context of HIV Infections, it is being evaluated for HSV-2 suppression to reduce maternal HIV-1 RNA levels during pregnancy and breastfeeding. The drug is an antiviral small molecule.
Valacyclovir is being developed by Royalty Pharma plc, which trades under the ticker RPRX. The company is conducting clinical research on the drug for HIV Infections, with the most recent trial completed in Kenya.
Valacyclovir is in Phase 2 clinical development for HIV Infections. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use. One Phase 2 trial has been completed, and the drug remains under clinical investigation.
Valacyclovir has one completed Phase 2 trial, NCT00530777, titled 'HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding.' The trial enrolled 148 female participants in Kenya and was randomized, double-blind, and placebo-controlled, with biomarker selection.