Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
This study has been completed.
Sponsor:
Glaxo Wellcome
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
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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 (Adult, Senior) |
| 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
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 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 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 |
ClinicalTrials.gov processed this record on September 30, 2016