A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
NCT ID: NCT00002000
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Valacyclovir hydrochloride
Acyclovir
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy.
Patients with the following are excluded:
* Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine.
* History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy.
Prior Medication:
Excluded:
* Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Univ of South Alabama
Mobile, Alabama, United States
ViRx Inc
San Francisco, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Denver Public Health Dept / Disease Control Services
Denver, Colorado, United States
West Haven Veterans Administration Med Ctr
West Haven, Connecticut, United States
Univ of South Florida
Tampa, Florida, United States
Emory Univ School of Medicine
Atlanta, Georgia, United States
Northwestern Memorial Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States
Louisiana State Univ Med School
New Orleans, Louisiana, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Roger Williams Med Ctr
Providence, Rhode Island, United States
Vanderbilt School of Medicine
Nashville, Tennessee, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States
Countries
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Other Identifiers
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08
Identifier Type: -
Identifier Source: secondary_id
104A
Identifier Type: -
Identifier Source: org_study_id