NCT00002026

Brief Summary

To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in the HL patient and compare to existing historical control data.

Trial Health

80
On Track

Trial Health Score

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

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

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

June 24, 2005

Status Verified

May 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Leukoplakia, HairyHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsLeukoplakia, OralHerpesvirus 4, HumanAcyclovirAIDS-Related Complex

Interventions

AcyclovirDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Topical antifungal therapy.
  • Patient must have:
  • Newly diagnosed clinical and histological hairy leukoplakia.
  • Positive HIV antibody by licensed ELISA or Western blot.

You may not qualify if:

  • Co-existing Condition:
  • Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.
  • Concurrent Medication:
  • Excluded within 2 weeks of study entry:
  • Systemic antifungal treatment.
  • Excluded within 6 weeks of study entry:
  • Immunomodulators.
  • Systemic antiviral treatment.
  • Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.
  • Prior Medication:
  • Excluded within 2 weeks of study entry:
  • Systemic antifungal.
  • Excluded within 6 weeks of study entry:
  • Immunomodulators.
  • Systemic antiviral treatment.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Related Publications (1)

  • Herbst JS, Morgan J, Raab-Traub N, Resnick L. Comparison of the efficacy of surgery and acyclovir therapy in oral hairy leukoplakia. J Am Acad Dermatol. 1989 Oct;21(4 Pt 1):753-6. doi: 10.1016/s0190-9622(89)70250-4.

    PMID: 2808791BACKGROUND

MeSH Terms

Conditions

Leukoplakia, HairyHIV InfectionsAIDS-Related Opportunistic InfectionsLeukoplakia, OralEpstein-Barr Virus InfectionsAIDS-Related Complex

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLeukoplakiaPrecancerous ConditionsMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsTumor Virus InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-05

Locations

US(1)