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

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.

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Key information

Conditions

Herpes Simplex AIDS-Related Complex Acquired Immunodeficiency Syndrome Anus Diseases Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Genital Diseases, Male HIV Infections Herpes Genitalis Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Intestinal Diseases Lentivirus Infections Male Urogenital Diseases RNA Virus Infections Rectal Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ of South Alabama, Mobile, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valacyclovir Hydrochloride

Drug

Acyclovir

Drug

Sponsors and collaborators

Lead sponsor

Glaxo Wellcome

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed