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A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of 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: NCT00002084
  Purpose

To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.


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

MedlinePlus related topics:   AIDS    Herpes Simplex   

ChemIDplus related topics:   Acyclovir    Acyclovir sodium    Valaciclovir    Valacyclovir hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • HIV infection with CD4 counts = or > 100 cells/mm3.
  • Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
  • History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.

Concurrent Medication:

Excluded:

  • Systemic antiherpes medication.
  • Interferon.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002084

Show 46 study locations  Show 46 Study Locations

Sponsors and Collaborators
Glaxo Wellcome
  More Information


Study ID Numbers:   104B, 07
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002084
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
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 October 10, 2008




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