Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

June 23, 2005 updated by: Glaxo Wellcome
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 900331079
        • Univ of Southern California / LA County USC Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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.

Exclusion Criteria

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.
  • Excluded within 8 weeks of study entry:
  • Zidovudine (AZT) or other antiretroviral therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 033A
  • 179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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