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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Acyclovir

Criteria

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.