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

GlaxoSmithKline (GSK) logo

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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