Completed

Valacyclovir Hydrochloride vs Acyclovir for Anogenital Herpes in HIV-Infected Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Valacyclovir hydrochloride

+ Acyclovir

Drug
Who is being recruted

Blood-Borne Infections+32

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+7 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 clinical trial is about comparing two medications, valacyclovir hydrochloride (256U87) and acyclovir, to treat recurrent anogenital herpes in HIV-infected patients with CD4 counts equal to or greater than 100 cells/mm3. The goal of this study is to find a safe and effective treatment option for these patients, addressing the need for better care in managing this condition. In this study, participants will receive either valacyclovir hydrochloride (256U87) or acyclovir orally. The study will evaluate the safety and efficacy of these medications by monitoring the frequency and severity of herpes outbreaks, as well as any potential side effects. This information will help determine which medication is more suitable for treating anogenital herpes in HIV-infected patients.

NCT00002084
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 DiseasesDigestive System DiseasesDNA Virus InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGenital Diseases, FemaleGenital Diseases, MaleHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsIntestinal DiseasesRectal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin Diseases, ViralSkin and Connective Tissue DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexAnus DiseasesHerpes GenitalisHerpes SimplexHIV Infections

Criteria

3 inclusion criteria required to participate
Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years
HIV infection with CD4 counts = or > 100 cells/mm3
History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study
4 exclusion criteria prevent from participating
History of hypersensitivity to acyclovir
Interferon
Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy
Systemic antiherpes medication

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 46 locations

Univ of South Alabama

Mobile, United StatesOpen Univ of South Alabama in Google Maps

Univ of Arizona / Health Science Ctr

Tucson, United States

Combat Group

Los Angeles, United States

Los Angeles County - USC Med Ctr

Los Angeles, United States
Completed46 Study Centers