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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002026
• Other study ID #: 033A
• Secondary ID: 179
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Leukoplakia
• Leukoplakia, Hairy

Intervention

Drug:
• Acyclovir

Locations

Country	Name	City	State
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation