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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