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Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients

Phase 2
Completed
Conditions
HIV Infections
Chickenpox
Registration Number
NCT00000953
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients.

HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.

Detailed Description

HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.

One hundred-eighty patients are randomized to receive either brovavir or acyclovir as follows: brovavir or its matching placebo once daily and acyclovir or its matching placebo five times daily. Treatment continues for 10 days. Entry into the study must occur within 72 hours of lesion development. Patients are followed in person daily or at regular intervals during study drug administration and on days 14, 21, and 28, and then monthly by telephone for 11 months thereafter.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
180
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (44)

Med College of Georgia

🇺🇸

Augusta, Georgia, United States

UCLA Med Ctr

🇺🇸

Los Angeles, California, United States

Veterans Administration Med Ctr

🇺🇸

Martinez, California, United States

Ohio State Univ / ACTU-Univ Clinic

🇺🇸

Columbus, Ohio, United States

Dallas Veterans Administration Med Ctr

🇺🇸

Dallas, Texas, United States

Univ of Texas, Southwestern Med Ctr of Dallas

🇺🇸

Dallas, Texas, United States

Univ TX Galveston Med Branch

🇺🇸

Galveston, Texas, United States

Massachusetts Gen Hosp / Harvard Med School

🇺🇸

Boston, Massachusetts, United States

Brigham and Women's Hosp

🇺🇸

Boston, Massachusetts, United States

New England Deaconess Hosp

🇺🇸

Boston, Massachusetts, United States

San Diego Naval Hosp

🇺🇸

San Diego, California, United States

Univ Dermatology Associates

🇺🇸

Cincinnati, Ohio, United States

Baylor College of Medicine

🇺🇸

Houston, Texas, United States

Univ TX San Antonio Health Science Ctr

🇺🇸

San Antonio, Texas, United States

Univ of Washington

🇺🇸

Seattle, Washington, United States

Veterans Administration Med Ctr / Community AIDS Program

🇺🇸

Washington, District of Columbia, United States

Univ of Colorado Health Sciences Ctr

🇺🇸

Denver, Colorado, United States

Mount Zion Med Ctr

🇺🇸

San Francisco, California, United States

Natl Institutes of Health / NIAID

🇺🇸

Bethesda, Maryland, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp

🇺🇸

Portland, Oregon, United States

Univ of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Univ of Southern California / LA County USC Med Ctr

🇺🇸

Los Angeles, California, United States

Infectious Disease Med Group

🇺🇸

Oakland, California, United States

George Washington Univ Med Ctr

🇺🇸

Washington, District of Columbia, United States

Rush Presbyterian - Saint Luke's Med Ctr

🇺🇸

Chicago, Illinois, United States

Johns Hopkins Hosp

🇺🇸

Baltimore, Maryland, United States

Beth Israel Hosp

🇺🇸

Boston, Massachusetts, United States

Washington Univ

🇺🇸

St Louis, Missouri, United States

Mount Sinai Med Ctr

🇺🇸

New York, New York, United States

Beth Israel Med Ctr

🇺🇸

New York, New York, United States

SUNY / Health Sciences Ctr at Stony Brook

🇺🇸

Stony Brook, New York, United States

Mem Sloan - Kettering Cancer Ctr

🇺🇸

New York, New York, United States

Carolinas Med Ctr

🇺🇸

Charlotte, North Carolina, United States

Saint Luke's - Roosevelt Hosp Ctr

🇺🇸

New York, New York, United States

SUNY / Health Sciences Ctr at Syracuse

🇺🇸

Syracuse, New York, United States

Dayton Veterans Administration Med Ctr

🇺🇸

Dayton, Ohio, United States

Med College of Ohio

🇺🇸

Toledo, Ohio, United States

Scott and White Hosp

🇺🇸

Temple, Texas, United States

Univ of Virginia Health Sciences Ctr

🇺🇸

Charlottesville, Virginia, United States

Salem Veterans Administration Med Ctr

🇺🇸

Salem, Virginia, United States

Virginia Clinical Research Inc

🇺🇸

Norfolk, Virginia, United States

Great Lakes Hemophilia Foundation

🇺🇸

Wauwatosa, Wisconsin, United States

Univ of Hawaii / Leahi Hosp

🇺🇸

Honolulu, Hawaii, United States

Univ of New Mexico

🇺🇸

Albuquerque, New Mexico, United States

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