Completed

Oral Acyclovir for Treatment and Suppression of Hairy Leukoplakia in ARC Patients

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What is being tested

Acyclovir

Drug
Who is being recruted

Blood-Borne Infections+31

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on treating and suppressing a condition called hairy leukoplakia (HL), which is related to the Epstein-Barr virus (EBV) and commonly affects individuals with AIDS-related complex (ARC). The goal is to evaluate the effectiveness of a drug called oral acyclovir (ACV) in managing this condition. The study also aims to understand the long-term safety of acyclovir for ARC patients with HL. It's important because it could potentially improve the care and quality of life for ARC patients dealing with HL. During the study, participants receive oral acyclovir as treatment. The study measures the effectiveness of the drug by observing the reduction of HL symptoms. It also monitors the progression of HIV disease in HL patients and compares this data to existing historical control data. This helps to understand the impact of the treatment on the overall health of the participants.

NCT00002026
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHead and Neck NeoplasmsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLeukoplakiaStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasmsNeoplasms by SiteOpportunistic InfectionsPrecancerous ConditionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPathological Conditions, AnatomicalAIDS-Related ComplexLeukoplakia, OralHIV InfectionsAIDS-Related Opportunistic InfectionsLeukoplakia, HairyEpstein-Barr Virus Infections

Criteria

3 inclusion criteria required to participate
Allowed: Topical antifungal therapy
Newly diagnosed clinical and histological hairy leukoplakia
Positive HIV antibody by licensed ELISA or Western blot
5 exclusion criteria prevent from participating
Immunomodulators within 6 weeks of study entry
Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded
Systemic antifungal treatment within 2 weeks of study entry
Systemic antiviral treatment within 6 weeks of study entry
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, United StatesOpen Univ of Southern California / LA County USC Med Ctr in Google Maps
CompletedOne Study Center