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

NCT ID: NCT00002084

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Herpes Simplex HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Valacyclovir hydrochloride

Intervention Type DRUG

Acyclovir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaxo Wellcome

INDUSTRY

Sponsor Role lead

Locations

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Univ of South Alabama

Mobile, Alabama, United States

Site Status

Univ of Arizona / Health Science Ctr

Tucson, Arizona, United States

Site Status

Combat Group

Los Angeles, California, United States

Site Status

Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

Infectious Disease Med Group / Adult Immunology Clinic

Oakland, California, United States

Site Status

UCI Med Ctr

Orange, California, United States

Site Status

UCSD Med Ctr

San Diego, California, United States

Site Status

San Diego Naval Hosp

San Diego, California, United States

Site Status

ViRx Inc

San Francisco, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Dr Marcus Conant

San Francisco, California, United States

Site Status

West Haven Veterans Administration Med Ctr

West Haven, Connecticut, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Whitman - Walker Clinic

Washington D.C., District of Columbia, United States

Site Status

George Washington Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States

Site Status

Univ of South Florida

St. Petersburg, Florida, United States

Site Status

Emory Univ School of Medicine

Atlanta, Georgia, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Northwestern Memorial Hosp

Chicago, Illinois, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Infectious Diseases Research Clinic / Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Univ of Iowa Hosp & Clinic

Iowa City, Iowa, United States

Site Status

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

Univ of Maryland at Baltimore

Baltimore, Maryland, United States

Site Status

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, United States

Site Status

Univ of Mississippi Med Ctr

Jackson, Mississippi, United States

Site Status

Univ of Missouri at Kansas City School of Medicine

Kansas City, Missouri, United States

Site Status

St Louis Univ

St Louis, Missouri, United States

Site Status

Beth Israel Med Ctr

New York, New York, United States

Site Status

Saint Vincent's Hosp and Med Ctr

New York, New York, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Univ of Rochester Med Ctr

Rochester, New York, United States

Site Status

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States

Site Status

Buckley Braffman Stern Med Associates

Philadelphia, Pennsylvania, United States

Site Status

Univ of Pittsburgh / Graduate School of Public Health

Pittsburgh, Pennsylvania, United States

Site Status

Roger Williams Med Ctr

Providence, Rhode Island, United States

Site Status

Regional Med Ctr at Memphis

Memphis, Tennessee, United States

Site Status

Dallas Associated Dermatologists

Dallas, Texas, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Thomas Audetta Clinic

Houston, Texas, United States

Site Status

Baylor College of Medicine / Texas Med Ctr

Houston, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

MacGregor Med Association

Houston, Texas, United States

Site Status

Univ TX Med Branch / Ctr for Clinical Studies

Nassau Bay, Texas, United States

Site Status

Med College of Virginia

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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07

Identifier Type: -

Identifier Source: secondary_id

104B

Identifier Type: -

Identifier Source: org_study_id