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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00079911 |
This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.
Condition | Intervention | Phase |
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Genital Herpes HIV Infection |
Drug: valacyclovir hydrochloride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Safety/Efficacy Study |
Official Title: | An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons With CD4+ Lymphocyte Count <100 Cells/mm3. |
Estimated Enrollment: | 162 |
Study Start Date: | March 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
GSK Investigational Site | |
Denver, Colorado, United States, 80204 | |
United States, Florida | |
GSK Investigational Site | |
Altamonte Springs, Florida, United States, 32701 | |
GSK Investigational Site | |
Fort Myers, Florida, United States, 33901 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60657 | |
United States, Massachusetts | |
GSK Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
United States, New Jersey | |
GSK Investigational Site | |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
GSK Investigational Site | |
Rochester, New York, United States, 14604 | |
United States, South Carolina | |
GSK Investigational Site | |
Columbia, South Carolina, United States, 29206-4713 | |
United States, Texas | |
GSK Investigational Site | |
Dallas, Texas, United States, 75246 | |
GSK Investigational Site | |
Fort Worth, Texas, United States, 76104 | |
Australia, New South Wales | |
GSK Investigational Site | |
Darlinghurst, New South Wales, Australia, 2010 | |
Hong Kong | |
GSK Investigational Site | |
Kowloon Bay, Hong Kong |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 100181 |
Study First Received: | March 18, 2004 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00079911 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
Herpes HIV HSV Genital Herpes |
Herpes Simplex Sexually Transmitted Diseases, Viral Herpes Genitalis Acquired Immunodeficiency Syndrome Genital Diseases, Male Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections |
Valacyclovir Virus Diseases Genital Diseases, Female Acyclovir HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Genital Diseases, Female Valacyclovir Therapeutic Uses Retroviridae Infections Herpes Simplex RNA Virus Infections Immune System Diseases Herpes Genitalis |
Acquired Immunodeficiency Syndrome Genital Diseases, Male Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Herpesviridae Infections Virus Diseases Acyclovir HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |