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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
This study has been completed.
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002000
  Purpose

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 Intervention
Herpes Simplex
HIV Infections
Drug: Valacyclovir hydrochloride
Drug: Acyclovir

MedlinePlus related topics: AIDS Herpes Simplex
Drug Information available for: Acyclovir Acyclovir sodium Valaciclovir Valacyclovir hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002000

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

Study ID Numbers: 104A, 08
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002000  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acyclovir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Anus Diseases
Herpes Genitalis

Study placed in the following topic categories:
Herpes Simplex
Sexually Transmitted Diseases, Viral
Skin Diseases
Herpes Genitalis
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Recurrence
Herpesviridae Infections
Valacyclovir
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Skin Diseases, Viral
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009