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

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Valacyclovir hydrochloride
Acyclovir
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Anus Diseases, Herpes Genitalis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of South Alabama
  • Univ of Arizona / Health Science Ctr
  • Combat Group
  • Los Angeles County - USC Med Ctr
  • Infectious Disease Med Group / Adult Immunology Clinic
  • UCI Med Ctr
  • UCSD Med Ctr
  • San Diego Naval Hosp
  • ViRx Inc
  • UCSF - San Francisco Gen Hosp
  • Dr Marcus Conant
  • West Haven Veterans Administration Med Ctr
  • Georgetown Univ Med Ctr
  • Whitman - Walker Clinic
  • George Washington Univ Med Ctr
  • Veterans Administration Med Ctr / Regional AIDS Program
  • Univ of South Florida
  • Emory Univ School of Medicine
  • AIDS Research Consortium of Atlanta
  • Northwestern Memorial Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Infectious Diseases Research Clinic / Indiana Univ Hosp
  • Univ of Iowa Hosp & Clinic
  • Univ of Kansas School of Medicine
  • Univ of Maryland at Baltimore
  • St Paul Ramsey Med Ctr
  • Univ of Mississippi Med Ctr
  • Univ of Missouri at Kansas City School of Medicine
  • St Louis Univ
  • Beth Israel Med Ctr
  • Saint Vincent's Hosp and Med Ctr
  • Mount Sinai Med Ctr
  • Univ of Rochester Med Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Buckley Braffman Stern Med Associates
  • Univ of Pittsburgh / Graduate School of Public Health
  • Roger Williams Med Ctr
  • Regional Med Ctr at Memphis
  • Dallas Associated Dermatologists
  • Univ TX Galveston Med Branch
  • Thomas Audetta Clinic
  • Baylor College of Medicine / Texas Med Ctr
  • Baylor College of Medicine
  • MacGregor Med Association
  • Univ TX Med Branch / Ctr for Clinical Studies
  • Med College of Virginia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002084
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, HIV Infections
Keywords
Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Anus Diseases, Herpes Genitalis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valacyclovir hydrochloride
Intervention Type
Drug
Intervention Name(s)
Acyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Univ of Arizona / Health Science Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Combat Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Infectious Disease Med Group / Adult Immunology Clinic
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
UCSD Med Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Diego Naval Hosp
City
San Diego
State/Province
California
ZIP/Postal Code
921345000
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Dr Marcus Conant
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
West Haven Veterans Administration Med Ctr
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Whitman - Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Veterans Administration Med Ctr / Regional AIDS Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Univ of South Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Infectious Diseases Research Clinic / Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Iowa Hosp & Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Univ of Maryland at Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
St Paul Ramsey Med Ctr
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Univ of Mississippi Med Ctr
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St Louis Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Pittsburgh / Graduate School of Public Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Regional Med Ctr at Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Dallas Associated Dermatologists
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Thomas Audetta Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Baylor College of Medicine / Texas Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MacGregor Med Association
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Univ TX Med Branch / Ctr for Clinical Studies
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Med College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
232980049
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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