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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002026
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Leukoplakia, Hairy

Keywords

AIDS-Related Opportunistic Infections, Leukoplakia, Oral, Herpesvirus 4, Human, Acyclovir, AIDS-Related Complex

Brief 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.

Interventions

DRUGAcyclovir

Sponsors

Glaxo Wellcome
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026