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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex; HIV Infections

Intervention: Valacyclovir hydrochloride (Drug); Acyclovir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Glaxo Wellcome


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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria 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. Exclusion Criteria 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.

Locations and Contacts

Univ of South Alabama, Mobile, Alabama 36604, United States

Univ of Arizona / Health Science Ctr, Tucson, Arizona 85724, United States

Combat Group, Los Angeles, California 90028, United States

Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States

Infectious Disease Med Group / Adult Immunology Clinic, Oakland, California 94609, United States

UCI Med Ctr, Orange, California 92668, United States

San Diego Naval Hosp, San Diego, California 921345000, United States

UCSD Med Ctr, San Diego, California 92103, United States

Dr Marcus Conant, San Francisco, California 94115, United States

UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States

ViRx Inc, San Francisco, California 94103, United States

West Haven Veterans Administration Med Ctr, West Haven, Connecticut 06516, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States

Whitman - Walker Clinic, Washington, District of Columbia 20009, United States

Univ of South Florida, St. Petersburg, Florida 33705, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, 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

Univ of Iowa Hosp & Clinic, Iowa City, Iowa 52242, United States

Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States

Univ of Maryland at Baltimore, Baltimore, Maryland 21201, United States

St Paul Ramsey Med Ctr, St. Paul, Minnesota 55101, United States

Univ of Mississippi Med Ctr, Jackson, Mississippi 39216, United States

Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri 64108, United States

St Louis Univ, St. Louis, Missouri 63104, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States

Univ of Rochester Med Ctr, Rochester, New York 14642, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States

Univ of Pittsburgh / Graduate School of Public Health, Pittsburgh, Pennsylvania 15261, United States

Roger Williams Med Ctr, Providence, Rhode Island 02908, United States

Regional Med Ctr at Memphis, Memphis, Tennessee 38103, United States

Dallas Associated Dermatologists, Dallas, Texas 75246, United States

Univ TX Galveston Med Branch, Galveston, Texas 77550, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Baylor College of Medicine / Texas Med Ctr, Houston, Texas 77030, United States

MacGregor Med Association, Houston, Texas 77054, United States

Thomas Audetta Clinic, Houston, Texas 77006, United States

Univ TX Med Branch / Ctr for Clinical Studies, Nassau Bay, Texas 77058, United States

Med College of Virginia, Richmond, Virginia 232980049, United States

Additional Information

Last updated: June 23, 2005

Page last updated: August 23, 2015

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