CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 148 enrolled
Drug / intervention
valacyclovir +1 moredrug
Likely dose
valacyclovir 500 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.

Search/NCT00530777
NCT00530777Phase 2Completed
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HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

University of Washington·interventional·Posted Sep 17, 2007·Updated Dec 19, 2018

In Brief

A Phase 2 clinical trial evaluating valacyclovir and placebo for HIV Infections and Herpes Simplex. Completed, enrolled 148 participants across 1 site.

Detailed Summary

In this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2 (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk and will decrease the risk of mother-to-child HIV-1 transmission (MTCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Herpes Simplex
CountriesKenya
CollaboratorsRoyalty Research Fund - University of Washington, Puget Sound Partners for Global Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 17, 2007
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.8 years ago

Interventions

valacyclovirdrug

500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum

placebodrug

oral placebo twice daily from 34 weeks gestation to 1 year postpartum