ClinicalTrials.gg
CompletedNCT00002026Updated Jun 24, 2005

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

An interventional study of Acyclovir in Leukoplakia, Hairy and HIV Infections, sponsored by Glaxo Wellcome. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Primary conditionAIDS-Related ComplexRegistry: HIV InfectionsReclassifiedWhy we changed it
Registry
HIV Infections — the first condition term the registry derived for this study.
ClinicalTrials.gg
AIDS-Related Complex
Why
  1. The study's title name AIDS-Related Complex, a narrower term within HIV Infections.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Glaxo Wellcome (part of GlaxoSmithKline) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in AIDS-Related Complex by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. AIDS-Related Complex · GlaxoSmithKline.

No phase
13 of 21
none open now
Registered
1st of 21
by date

Among the 21 studies in AIDS-Related Complex by GlaxoSmithKline, this one is one of 13 with no phase, and was the 1st registered.

AIDS-Related Complex

283 studies on the registry are indexed under AIDS-Related Complex; 2 are open to participants now.

Browse AIDS-Related Complex studies →

Open to participants now

None of the 21 studies in AIDS-Related Complex by GlaxoSmithKline is open now. The open studies under AIDS-Related Complex, anywhere →

Where they have run

Who these studies take

Of the 2 AIDS-Related Complex studies recruiting now, 1 sets no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 21 studies in AIDS-Related Complex by GlaxoSmithKline as a file.
02

Study 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.

03

Conditions studied

  • Leukoplakia, Hairy
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Leukoplakia, Oral
  • Herpesvirus 4, Human
  • Acyclovir
  • AIDS-Related Complex
04

In context

AIDS-Related Complex Reclassified

283 studies on the registry are indexed under AIDS-Related Complex; 2 are open to participants now.

Browse AIDS-Related Complex studies →

Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

First submitted before Glaxo Wellcome became part of GlaxoSmithKline.

Compared within AIDS-Related Complex, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Concurrent Medication:

Allowed:

  • Topical antifungal therapy.

Patient must have:

  • Newly diagnosed clinical and histological hairy leukoplakia.
  • Positive antibody by licensed ELISA or Western blot.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

06

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

07

Study locations

1 site
  • Univ of Southern California / LA County USC Med Ctr
    Los Angeles, California 900331079, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00002026
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 1990. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Acyclovir

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