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OpenTrials
Completed

NCT Number: NCT00002026

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.

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Key information

Conditions

Leukoplakia, Hairy AIDS-Related Complex AIDS-Related Opportunistic Infections Blood-Borne Infections Communicable Diseases DNA Virus Infections Epstein-Barr Virus Infections Genital Diseases HIV Infections Head and Neck Neoplasms Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Leukoplakia Leukoplakia, Oral Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Opportunistic Infections Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acyclovir

Drug

Sponsors and collaborators

Lead sponsor

Glaxo Wellcome

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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