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valacyclovir

Phase 2

HIV Infections | Small molecule | Infectious Disease |Royalty Pharma plc|Last Updated: Dec 19, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment148

FDA Designations

No designations recorded

Clinical trial landscape

valacyclovir · 1 trial · 2 indications

Phase 2 1
NCT00530777HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and BreastfeedingHIV Infections
COMPLETED148 Analytics
PHASE2COMPLETED
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation
4 weeks

Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation

Secondary Endpoints

Vertical HIV-1 Transmission
1 year postpartum
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
2PLACEBO_COMPARATORoral placebo twice daily from 34 weeks gestation to 1 year postpartum

Interventions

NameTypeDescription
valacyclovirDRUG500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
placeboDRUGoral placebo twice daily from 34 weeks gestation to 1 year postpartum
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

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...

Countries:Kenya
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Frequently asked questions about valacyclovir

What is valacyclovir used for in HIV Infections?

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.

What does valacyclovir target?

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.

Who is developing valacyclovir?

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.

What phase is valacyclovir in?

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.

What clinical trials is valacyclovir in?

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.