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

Completed · Not applicable

Conditions studied: Herpes Simplex, HIV Infections

In brief

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).

Key facts

Study ID

NCT00002000

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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