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valacyclovir

Phase 3

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 22, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00378976HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.PHASE3 COMPLETED 20Aug 1, 2003Jul 1, 2004Aug 22, 20131 Peru
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Study Endpoints
Primary Endpoints
Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation.
18 weeks
Secondary Endpoints
Evaluate HSV-2 suppression with decreased plasma HIV RNA levels
18 weeks
Assess the effect of daily valacyclovir on pharyngeal shedding in HSV-1 seropositive individuals
18 weeks
Determine the temporal pattern of HIV shedding in the rectum, pharynx and semen with respect to mucosal HSV-1 and HSV-2 reactivation; Determine HSV-2 suppression and HIV replication within rectal mucosa.
18 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
valacyclovirDRUG500 mg twice-daily oral
matching placeboDRUGtwice daily as per experimental drug
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Greater than 18 years old, * Documented HIV-1 seropositive, * CD4 count greater than 200, * Not on HIV antiretroviral therapy, * HSV-2 seropositive as determined by Focus EIA (IN \>3.5) * Not intending to move out of the area for the duration of study participation. * Willing ...

Countries:Peru
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