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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002000
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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).

Condition Intervention
Herpes Simplex HIV Infections Drug: Valacyclovir hydrochloride Drug: Acyclovir

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002000


  Show 22 Study Locations
Sponsors and Collaborators
Glaxo Wellcome
  More Information

ClinicalTrials.gov Identifier: NCT00002000     History of Changes
Other Study ID Numbers: 104A
08
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: April 1996

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:
Sexually Transmitted Diseases, Viral
Infection
Communicable Diseases
HIV Infections
Herpes Simplex
Herpesviridae Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents