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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002026
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1990
  Purpose

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.


Condition Intervention
Leukoplakia, Hairy
HIV Infections
Drug: Acyclovir

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002026

Locations
United States, California
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Sponsors and Collaborators
Glaxo Wellcome
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002026     History of Changes
Other Study ID Numbers: 033A, 179
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Leukoplakia, Oral
Herpesvirus 4, Human
Acyclovir
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Leukoplakia
Leukoplakia, Hairy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Leukoplakia, Oral
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014