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
2 other identifiers
interventional
N/A
1 country
22
Brief Summary
To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
22 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have the following:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (22)
Univ of South Alabama
Mobile, Alabama, 36604, United States
ViRx Inc
San Francisco, California, 94103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Denver Public Health Dept / Disease Control Services
Denver, Colorado, 80204, United States
West Haven Veterans Administration Med Ctr
West Haven, Connecticut, 06516, United States
Univ of South Florida
Tampa, Florida, 33612, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Northwestern Memorial Hosp
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Louisiana State Univ Med School
New Orleans, Louisiana, 701122822, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39216, United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670560, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Vanderbilt School of Medicine
Nashville, Tennessee, 37232, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04