Completed
Valacyclovir vs Acyclovir for Recurrent Anogenital Herpes in HIV Patients
What is being tested
Valacyclovir hydrochloride
+ Acyclovir
Drug
Who is being recruted
Blood-Borne Infections+32
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.
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 13 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
2 inclusion criteria required to participate
HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes
Signed the consent form or present a signed parental consent form if below 18 years
5 exclusion criteria prevent from participating
Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase
History of hypersensitivity to acyclovir
Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine
Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy
Show More Criteria
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 22 locations
ViRx Inc
San Francisco, United StatesUCSF - San Francisco Gen Hosp
San Francisco, United StatesDenver Public Health Dept / Disease Control Services
Denver, United StatesCompleted22 Study Centers