A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients - Tabular View

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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.
Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
Official Title ^†	A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Herpes Simplex HIV Infections
Intervention ^†	Drug: Valacyclovir hydrochloride Drug: Acyclovir
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
Eligibility 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002084
Organization ID	104B
Secondary IDs ^††	07
Study Sponsor ^†	Glaxo Wellcome
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1996
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.