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A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent 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

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

Inclusion Criteria Patients must have the following: HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes. Signed the consent form or present a signed parental consent form if below 18 years. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy. Patients with the following are excluded: Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy. Prior Medication: Excluded: Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.

Sites / Locations

  • Univ of South Alabama
  • ViRx Inc
  • UCSF - San Francisco Gen Hosp
  • Denver Public Health Dept / Disease Control Services
  • West Haven Veterans Administration Med Ctr
  • Univ of South Florida
  • Emory Univ School of Medicine
  • Northwestern Memorial Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Infectious Diseases Research Clinic / Indiana Univ Hosp
  • Louisiana State Univ Med School
  • Univ of Mississippi Med Ctr
  • Univ of New Mexico School of Medicine
  • Saint Vincent's Hosp and Med Ctr
  • Univ of Cincinnati
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Roger Williams Med Ctr
  • Vanderbilt School of Medicine
  • Univ TX Galveston Med Branch
  • Baylor College of Medicine
  • Infectious Disease Physicians Inc
  • Univ of Washington / Pacific Med Ctr

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
NCT00002000
Brief Title
A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
Official Title
A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent 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 evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).
Detailed Description
Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.

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
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have the following: HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes. Signed the consent form or present a signed parental consent form if below 18 years. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy. Patients with the following are excluded: Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy. Prior Medication: Excluded: Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.
Facility Information:
Facility Name
Univ of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
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
Denver Public Health Dept / Disease Control Services
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
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
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
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
Louisiana State Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122822
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 New Mexico School of Medicine
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
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
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670560
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
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Vanderbilt School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Univ of Washington / Pacific Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

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A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients

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