A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
Herpes Simplex, HIV Infections
About this trial
This is an interventional treatment trial for Herpes Simplex focused on measuring Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Anus Diseases, Herpes Genitalis
Eligibility 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.
Sites / Locations
- Univ of South Alabama
- ViRx Inc
- UCSF - San Francisco Gen Hosp
- Denver Public Health Dept / Disease Control Services
- West Haven Veterans Administration Med Ctr
- Univ of South Florida
- Emory Univ School of Medicine
- Northwestern Memorial Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Infectious Diseases Research Clinic / Indiana Univ Hosp
- Louisiana State Univ Med School
- Univ of Mississippi Med Ctr
- Univ of New Mexico School of Medicine
- Saint Vincent's Hosp and Med Ctr
- Univ of Cincinnati
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Roger Williams Med Ctr
- Vanderbilt School of Medicine
- Univ TX Galveston Med Branch
- Baylor College of Medicine
- Infectious Disease Physicians Inc
- Univ of Washington / Pacific Med Ctr