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).
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.
Univ of South Alabama, Mobile, Alabama 36604, United States
UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States
ViRx Inc, San Francisco, California 94103, United States
Denver Public Health Dept / Disease Control Services, Denver, Colorado 80204, United States
West Haven Veterans Administration Med Ctr, West Haven, Connecticut 06516, United States
Univ of South Florida, Tampa, Florida 33612, United States
Emory Univ School of Medicine, Atlanta, Georgia 30303, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Northwestern Memorial Hosp, Chicago, Illinois 60611, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Louisiana State Univ Med School, New Orleans, Louisiana 701122822, United States
Univ of Mississippi Med Ctr, Jackson, Mississippi 39216, United States
Univ of New Mexico School of Medicine, Albuquerque, New Mexico 87131, United States
Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States
Univ of Cincinnati, Cincinnati, Ohio 452670560, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States
Roger Williams Med Ctr, Providence, Rhode Island 02908, United States
Vanderbilt School of Medicine, Nashville, Tennessee 37232, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States
Univ of Washington / Pacific Med Ctr, Seattle, Washington 98144, United States
