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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002084
• Other study ID #: 104B
• Secondary ID: 07
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• Herpesviridae Infections
• HIV Infections
• Infection

Intervention

Drug:
• Valacyclovir hydrochloride

• Acyclovir

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Univ of Maryland at Baltimore	Baltimore	Maryland
United States	Northwestern Memorial Hosp	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Dallas Associated Dermatologists	Dallas	Texas
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor College of Medicine / Texas Med Ctr	Houston	Texas
United States	MacGregor Med Association	Houston	Texas
United States	Thomas Audetta Clinic	Houston	Texas
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Iowa Hosp & Clinic	Iowa City	Iowa
United States	Univ of Mississippi Med Ctr	Jackson	Mississippi
United States	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri
United States	Combat Group	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Regional Med Ctr at Memphis	Memphis	Tennessee
United States	Univ of South Alabama	Mobile	Alabama
United States	Univ TX Med Branch / Ctr for Clinical Studies	Nassau Bay	Texas
United States	Beth Israel Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	Infectious Disease Med Group / Adult Immunology Clinic	Oakland	California
United States	UCI Med Ctr	Orange	California
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Univ of Pittsburgh / Graduate School of Public Health	Pittsburgh	Pennsylvania
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Roger Williams Med Ctr	Providence	Rhode Island
United States	Med College of Virginia	Richmond	Virginia
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	San Diego Naval Hosp	San Diego	California
United States	UCSD Med Ctr	San Diego	California
United States	Dr Marcus Conant	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	St Louis Univ	St. Louis	Missouri
United States	St Paul Ramsey Med Ctr	St. Paul	Minnesota
United States	Univ of South Florida	St. Petersburg	Florida
United States	Univ of Arizona / Health Science Ctr	Tucson	Arizona
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia
United States	Whitman - Walker Clinic	Washington	District of Columbia
United States	West Haven Veterans Administration Med Ctr	West Haven	Connecticut
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,