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CompletedNCT00002000Updated Jun 24, 2005

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

An interventional study of Valacyclovir hydrochloride and Acyclovir in Herpes Simplex and HIV Infections, sponsored by Glaxo Wellcome. Completed at 22 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Glaxo Wellcome · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
13 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Herpes Simplex
  • HIV Infections

Keywords

  • Acyclovir
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • Anus Diseases
  • Herpes Genitalis
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

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Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

  • DrugValacyclovir hydrochloride
  • DrugAcyclovir
06

Study locations

22 sites
  • Univ of South Alabama
    Mobile, Alabama 36604, United States
  • ViRx Inc
    San Francisco, California 94103, United States
  • UCSF - San Francisco Gen Hosp
    San Francisco, California 94110, United States
  • Denver Public Health Dept / Disease Control Services
    Denver, Colorado 80204, United States
  • West Haven Veterans Administration Med Ctr
    West Haven, Connecticut 06516, United States
  • Univ of South Florida
    Tampa, Florida 33612, United States
  • Emory Univ School of Medicine
    Atlanta, Georgia 30303, United States
  • Northwestern Memorial Hosp
    Chicago, Illinois 60611, United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago, Illinois 60612, United States
  • Infectious Diseases Research Clinic / Indiana Univ Hosp
    Indianapolis, Indiana 46202, United States
  • Louisiana State Univ Med School
    New Orleans, Louisiana 701122822, United States
  • Univ of Mississippi Med Ctr
    Jackson, Mississippi 39216, United States
  • Univ of New Mexico School of Medicine
    Albuquerque, New Mexico 87131, United States
  • Saint Vincent's Hosp and Med Ctr
    New York, New York 10011, United States
  • Univ of Cincinnati
    Cincinnati, Ohio 452670560, United States
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    Portland, Oregon 97210, United States
  • Roger Williams Med Ctr
    Providence, Rhode Island 02908, United States
  • Vanderbilt School of Medicine
    Nashville, Tennessee 37232, United States
  • Univ TX Galveston Med Branch
    Galveston, Texas 77550, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Infectious Disease Physicians Inc
    Annandale, Virginia 22203, United States
  • Univ of Washington / Pacific Med Ctr
    Seattle, Washington 98144, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002000
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

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