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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002084
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Univ of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
United States, California
Combat Group
Los Angeles, California, United States, 90028
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, United States, 94609
UCI Med Ctr
Orange, California, United States, 92668
UCSD Med Ctr
San Diego, California, United States, 92103
San Diego Naval Hosp
San Diego, California, United States, 921345000
ViRx Inc
San Francisco, California, United States, 94103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Dr Marcus Conant
San Francisco, California, United States, 94115
United States, Connecticut
West Haven Veterans Administration Med Ctr
West Haven, Connecticut, United States, 06516
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Whitman - Walker Clinic
Washington, District of Columbia, United States, 20009
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
Veterans Administration Med Ctr / Regional AIDS Program
Washington, District of Columbia, United States, 20422
United States, Florida
Univ of South Florida
St. Petersburg, Florida, United States, 33705
United States, Georgia
Emory Univ School of Medicine
Atlanta, Georgia, United States, 30303
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Northwestern Memorial Hosp
Chicago, Illinois, United States, 60611
United States, Indiana
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Iowa
Univ of Iowa Hosp & Clinic
Iowa City, Iowa, United States, 52242
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Maryland
Univ of Maryland at Baltimore
Baltimore, Maryland, United States, 21201
United States, Minnesota
St Paul Ramsey Med Ctr
St. Paul, Minnesota, United States, 55101
United States, Mississippi
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39216
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
St Louis Univ
St. Louis, Missouri, United States, 63104
United States, New York
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
Beth Israel Med Ctr
New York, New York, United States, 10003
Mount Sinai Med Ctr
New York, New York, United States, 10029
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Roger Williams Med Ctr
Providence, Rhode Island, United States, 02908
United States, Tennessee
Regional Med Ctr at Memphis
Memphis, Tennessee, United States, 38103
United States, Texas
Dallas Associated Dermatologists
Dallas, Texas, United States, 75246
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Baylor College of Medicine / Texas Med Ctr
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
Thomas Audetta Clinic
Houston, Texas, United States, 77006
MacGregor Med Association
Houston, Texas, United States, 77054
Univ TX Med Branch / Ctr for Clinical Studies
Nassau Bay, Texas, United States, 77058
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 232980049
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002084     History of Changes
Other Study ID Numbers: 104B, 07
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Simplex
Herpesviridae Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014