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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment

Interventions

  • Drug: Acyclovir

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Glaxo Wellcome

References

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.

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