At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 28 enrolled
Drug / intervention
valacyclovir +1 moredrug
Likely dose
valacyclovir 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, Crossover Trial of the Effect of Dosing of Daily HSV-2 Suppressive Therapy on HSV Reactivation and Plasma HIV-1 Levels Among HIV-1/ HSV-2 Co-infected Persons
In Brief
A Phase 4 clinical trial evaluating valacyclovir and acyclovir for Genital Herpes and HIV Infection. Completed, enrolled 28 participants across 1 site.
Detailed Summary
To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valacyclovir will result in greater reduction in plasma HIV-1 and genital HSV reactivation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenital Herpes, HIV Infection
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartDec 2007
Primary CompletionMar 2011
TodayJul 2026
First PostedSep 11, 2007
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.8 years ago
Interventions
valacyclovirdrug
valacyclovir 1000 mg orally twice daily for 12 weeks.
acyclovirdrug
acyclovir 400 mg orally twice daily for 12 weeks.