NCT00002404

Brief Summary

The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

January 29, 2008

Status Verified

June 1, 1999

First QC Date

November 2, 1999

Last Update Submit

January 24, 2008

Conditions

Herpes SimplexHIV Infections

Keywords

HIV-1Antiviral AgentsHerpes GenitalisRecurrenceDNA, ViralRNA, ViralvalacyclovirHerpesvirus 2, Human

Interventions

Valacyclovir hydrochlorideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • Serologically documented HSV-2 and HIV-1 infection.
  • History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
  • No contraindications to valacyclovir.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Hepatic impairment.
  • Impaired renal function (creatinine above 2 mg/dl).
  • Malabsorption syndrome or other gastrointestinal dysfunction.
  • Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.
  • Patients with the following prior conditions are excluded:
  • History of hypersensitivity to acyclovir or valacyclovir.
  • Prior Medication:
  • Excluded:
  • Participation in any investigational drug trial within 1 month prior to entry on study.
  • Systemic anti-HSV therapy within 7 days prior to start of study drug.
  • \. Probenecid.
  • Suppressive treatment with medication that has anti-HSV activity.
  • Required:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Herpes SimplexHIV InfectionsHerpes GenitalisRecurrence

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 DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

January 29, 2008

Record last verified: 1999-06