Clinical trial NCT00002084: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex
HIV Infections
Keywords: Acyclovir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Anus Diseases
Herpes Genitalis
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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.

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