Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV) - Full Text View

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002026

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

MedlinePlus related topics: AIDS

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

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

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

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.

Study ID Numbers:	033A, 179
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002026
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

Study placed in the following topic categories:

Mouth Diseases
Pathological Conditions, Anatomical
Opportunistic Infections
Leukoplakia, Oral
Sexually Transmitted Diseases, Viral
Precancerous Conditions
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Mouth Neoplasms
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases

Acyclovir
HIV Infections
Oral cancer
Head and Neck Neoplasms
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Leukoplakia
DNA Virus Infections
Epstein-Barr Virus Infections
Stomatognathic Diseases
Leukoplakia, Hairy
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms
RNA Virus Infections
Neoplasms by Site
Slow Virus Diseases
Immune System Diseases

Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009