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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Leukoplakia, Hairy; HIV Infections

Treatments: Drug: Acyclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002026

033A

179

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.