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Anti-viral

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Phase 4
Waitlist Available
Led By Jared Baeten, MD, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks (12 weeks per drug intervention)
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • HIV/AIDS
  • Genital Herpes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks (12 weeks per drug intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks (12 weeks per drug intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acyclovir
The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.
Secondary study objectives
Sub-Study: To Evaluate the Kinetics of Plasma HIV-1 Decline Over the First Three Days of High-dose Valacyclovir Administration.
The Effect of Valacyclovir 1 Gram Twice Daily Compared to Acyclovir 400 mg Twice Daily on the Percentage of Days With Genital Herpes Lesions.
Acyclovir

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-dose valacyclovirExperimental Treatment1 Intervention
valacyclovir 1000 mg orally twice daily for 12 weeks.
Group II: Standard-dose acyclovirActive Control1 Intervention
acyclovir 400 mg orally twice daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valaciclovir
FDA approved

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,815 Previous Clinical Trials
8,384,542 Total Patients Enrolled
University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,541 Total Patients Enrolled
Jared Baeten, MD, PhDPrincipal InvestigatorUniversity of Washington
8 Previous Clinical Trials
18,379 Total Patients Enrolled
Anna Wald, MD, MPHStudy DirectorUniversity of Washington
11 Previous Clinical Trials
7,732 Total Patients Enrolled
~2 spots leftby Dec 2025
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