NCT00161434

Brief Summary

The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 10, 2008

Status Verified

December 1, 2007

Enrollment Period

3.3 years

First QC Date

September 8, 2005

Last Update Submit

December 29, 2007

Conditions

Herpes SimplexHIV Infections

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

  • To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.

    18 weeks

Secondary Outcomes (1)

  • To quantify increase in rectal and pharyngeal HIV-1 shedding associated with HSV-1 and HSV-2 reactivation. To determine reduction in systemic HIV RNA during valacyclovir therapy. To evaluate reduction in inflammatory cells and HIV replication.

    18 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: valacyclovir

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

valacyclovirDRUG

1 gram daily for 8 weeks

Also known as: Valtrex
1
placeboDRUG

matching placebo for 8 weeks

2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV seropositive and HSV-2 seropositive
  • MSM (men having sex with men)
  • years old or older

You may not qualify if:

  • Known history of adverse reaction to acyclovir or valacyclovir
  • Planned open label use of acyclovir, valacyclovir or famciclovir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virology Research Clinic

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Herpes SimplexHIV Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anna Wald, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 10, 2008

Record last verified: 2007-12

Locations

US(1)