Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukoplakia, Hairy; HIV Infections
Intervention: Acyclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
Official title: Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Study design: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California 900331079, United States
Additional Information
Related publications: 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.
Last updated: June 23, 2005
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