A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

Completed · Not applicable

Conditions studied: Herpes Simplex, HIV Infections

In brief

To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or \> 100 cells/mm3.

Key facts

Study ID

NCT00002084

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV infection with CD4 counts = or > 100 cells/mm3.
• Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
• History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.
• Concurrent Medication:
• Excluded:
• Systemic antiherpes medication.
• Interferon.
• Patients with the following prior conditions are excluded:
• History of hypersensitivity to acyclovir.

Where it is running

• Univ of South Alabama — Mobile, Alabama, United States
• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States
• Combat Group — Los Angeles, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Infectious Disease Med Group / Adult Immunology Clinic — Oakland, California, United States
• UCI Med Ctr — Orange, California, United States
• UCSD Med Ctr — San Diego, California, United States
• San Diego Naval Hosp — San Diego, California, United States
• ViRx Inc — San Francisco, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Dr Marcus Conant — San Francisco, California, United States
• West Haven Veterans Administration Med Ctr — West Haven, Connecticut, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Whitman - Walker Clinic — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
• Univ of South Florida — St. Petersburg, Florida, United States
• Emory Univ School of Medicine — Atlanta, Georgia, United States
• AIDS Research Consortium of Atlanta — 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
• Univ of Iowa Hosp & Clinic — Iowa City, Iowa, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Univ of Maryland at Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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