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).

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

Further Study Details: 

Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Alabama
      Univ of South Alabama, Mobile,  Alabama,  36604,  United States
California
      UCSF - San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      ViRx Inc, San Francisco,  California,  94103,  United States
Colorado
      Denver Public Health Dept / Disease Control Services, Denver,  Colorado,  80204,  United States
Connecticut
      West Haven Veterans Administration Med Ctr, West Haven,  Connecticut,  06516,  United States
Florida
      Univ of South Florida, Tampa,  Florida,  33612,  United States
Georgia
      Emory Univ School of Medicine, Atlanta,  Georgia,  30303,  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
Louisiana
      Louisiana State Univ Med School, New Orleans,  Louisiana,  701122822,  United States
Mississippi
      Univ of Mississippi Med Ctr, Jackson,  Mississippi,  39216,  United States
New Mexico
      Univ of New Mexico School of Medicine, Albuquerque,  New Mexico,  87131,  United States
New York
      Saint Vincent's Hosp and Med Ctr, New York,  New York,  10011,  United States
Ohio
      Univ of Cincinnati, Cincinnati,  Ohio,  452670560,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Rhode Island
      Roger Williams Med Ctr, Providence,  Rhode Island,  02908,  United States
Tennessee
      Vanderbilt School of Medicine, Nashville,  Tennessee,  37232,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States
Washington
      Univ of Washington / Pacific Med Ctr, Seattle,  Washington,  98144,  United States

Study ID Numbers:  104A; 08
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002000
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08