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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

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

Summary

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).

Clinical Details

Official title: 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

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

Detailed description: 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.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): 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.

Locations and Contacts

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

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

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

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

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

Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States

Univ of Washington / Pacific Med Ctr, Seattle, Washington 98144, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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