Leukoplakia, HairyNCT00002026
Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
A study testing Acyclovir in people with Leukoplakia, Hairy and HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukoplakia, Hairy, HIV Infections
- What is being tested?
- Acyclovir
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
About this study
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.
- Conditions
- Leukoplakia, Hairy, HIV Infections
- Being tested
- Acyclovir
- Keywords
- AIDS-Related Opportunistic Infections, Leukoplakia, Oral, Herpesvirus 4, Human, Acyclovir, AIDS-Related Complex
- Medical subject headings
- Leukoplakia, Hairy, HIV Infections, AIDS-Related Opportunistic Infections, Leukoplakia, Oral, Epstein-Barr Virus Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukoplakia, HairyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002026
- Sponsor's protocol ID
- 033A
- Other IDs
- 179
- Status last verified
- May 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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. doi: 10.1016/s0190-9622(89)70250-4.
PubMed 2808791
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
- ClinicalTrials.gov ID
- NCT00002026
- Acronym / sponsor ID
- 033A
- Conditions
- Leukoplakia, Hairy, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Leukoplakia, Oral, Herpesvirus 4, Human, Acyclovir, AIDS-Related Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Topical antifungal therapy.
- Newly diagnosed clinical and histological hairy leukoplakia.
- Positive HIV antibody by licensed ELISA or Western blot.
Key exclusion criteria (17 listed)
- Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.
- Systemic antifungal treatment.
- Excluded within 6 weeks of study entry:
- Immunomodulators.
- Systemic antiviral treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 2808791Herbst 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acyclovir in people with Leukoplakia, Hairy and HIV Infections, run by Glaxo Wellcome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.