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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002084

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:	Treatment, Safety Study
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:

MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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

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

Show 46 Study Locations

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

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

Study placed in the following topic categories:

Herpes Simplex
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Skin Diseases
Herpes Genitalis
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Immunologic Deficiency Syndromes

Herpesviridae Infections
Valacyclovir
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Valacyclovir
Therapeutic Uses
Retroviridae Infections
Herpes Simplex
RNA Virus Infections
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome

Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Acyclovir
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 02, 2009