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

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ClinicalTrials.gov Identifier: NCT00002026
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

November 2, 1999
August 31, 2001
June 24, 2005
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No Changes Posted
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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)
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.
Not Provided
Interventional
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Primary Purpose: Treatment
  • Leukoplakia, Hairy
  • HIV Infections
Drug: Acyclovir
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002026
033A
179
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
May 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP