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.

Condition	Treatment or Intervention
Herpes Simplex HIV Infections	Drug: Valacyclovir hydrochloride  Drug: Acyclovir

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Alabama
      Univ of South Alabama, Mobile,  Alabama,  36604,  United States
Arizona
      Univ of Arizona / Health Science Ctr, Tucson,  Arizona,  85724,  United States
California
      UCSF - San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      ViRx Inc, San Francisco,  California,  94103,  United States
      Dr Marcus Conant, San Francisco,  California,  94115,  United States
      UCI Med Ctr, Orange,  California,  92668,  United States
      Infectious Disease Med Group / Adult Immunology Clinic, Oakland,  California,  94609,  United States
      UCSD Med Ctr, San Diego,  California,  92103,  United States
      Combat Group, Los Angeles,  California,  90028,  United States
      San Diego Naval Hosp, San Diego,  California,  921345000,  United States
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
Connecticut
      West Haven Veterans Administration Med Ctr, West Haven,  Connecticut,  06516,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
      Whitman - Walker Clinic, Washington,  District of Columbia,  20009,  United States
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
      Veterans Administration Med Ctr / Regional AIDS Program, Washington,  District of Columbia,  20422,  United States
Florida
      Univ of South Florida, St. Petersburg,  Florida,  33705,  United States
Georgia
      Emory Univ School of Medicine, Atlanta,  Georgia,  30303,  United States
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      Northwestern Memorial Hosp, Chicago,  Illinois,  60611,  United States
Indiana
      Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States
Iowa
      Univ of Iowa Hosp & Clinic, Iowa City,  Iowa,  52242,  United States
Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States
Maryland
      Univ of Maryland at Baltimore, Baltimore,  Maryland,  21201,  United States
Minnesota
      St Paul Ramsey Med Ctr, St. Paul,  Minnesota,  55101,  United States
Mississippi
      Univ of Mississippi Med Ctr, Jackson,  Mississippi,  39216,  United States
Missouri
      Univ of Missouri at Kansas City School of Medicine, Kansas City,  Missouri,  64108,  United States
      St Louis Univ, St. Louis,  Missouri,  63104,  United States
New York
      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
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Pennsylvania
      Univ of Pittsburgh / Graduate School of Public Health, Pittsburgh,  Pennsylvania,  15261,  United States
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Rhode Island
      Roger Williams Med Ctr, Providence,  Rhode Island,  02908,  United States
Tennessee
      Regional Med Ctr at Memphis, Memphis,  Tennessee,  38103,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Baylor College of Medicine / Texas Med Ctr, Houston,  Texas,  77030,  United States
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States
      Univ TX Med Branch / Ctr for Clinical Studies, Nassau Bay,  Texas,  77058,  United States
      Thomas Audetta Clinic, Houston,  Texas,  77006,  United States
      MacGregor Med Association, Houston,  Texas,  77054,  United States
      Dallas Associated Dermatologists, Dallas,  Texas,  75246,  United States
Virginia
      Med College of Virginia, Richmond,  Virginia,  232980049,  United States

Study ID Numbers:  104B; 07
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002084
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08