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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Acyclovir Acyclovir sodium

Genetic and Rare Diseases Information Center resources: Leukoplakia Oral Cancer

U.S. FDA Resources

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:

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.


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:


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

ClinicalTrials.gov processed this record on February 26, 2015

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