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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acyclovir

About this trial

This is an interventional treatment trial for Leukoplakia, Hairy focused on measuring AIDS-Related Opportunistic Infections, Leukoplakia, Oral, Herpesvirus 4, Human, Acyclovir, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Univ of Southern California / LA County USC Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002026

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Glaxo Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT00002026

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 1990

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukoplakia, Hairy, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Leukoplakia, Oral, Herpesvirus 4, Human, Acyclovir, AIDS-Related Complex

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Acyclovir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Univ of Southern California / LA County USC Med Ctr

City

Los Angeles

State/Province

California

ZIP/Postal Code

900331079

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

2808791

Citation

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. doi: 10.1016/s0190-9622(89)70250-4.

Results Reference

background

Leukoplakia, Hairy, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial