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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000953 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Chickenpox |
Drug: Sorivudine Drug: Acyclovir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Evaluation of Brovavir ( BV-Ara-U; SQ 32,756 ) Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients |
| Estimated Enrollment: | 180 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Concurrent Medication:
Excluded during acute phase of study:
Use of the following drugs is discouraged during the long-term phase of the study:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 1 month prior to entry:
Excluded within 2 weeks prior to entry:
Excluded within 72 hours prior to entry:
Alcohol or drug abuse.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| UCLA Med Ctr | |
| Los Angeles, California, United States, 90095 | |
| San Diego Naval Hosp | |
| San Diego, California, United States, 92134 | |
| Mount Zion Med Ctr | |
| San Francisco, California, United States, 94115 | |
| Veterans Administration Med Ctr | |
| Martinez, California, United States, 94553 | |
| Infectious Disease Med Group | |
| Oakland, California, United States, 94609 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr / Community AIDS Program | |
| Washington, District of Columbia, United States, 20422 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Georgia | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Hawaii | |
| Univ of Hawaii / Leahi Hosp | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Natl Institutes of Health / NIAID | |
| Bethesda, Maryland, United States, 20892 | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Massachusetts Gen Hosp / Harvard Med School | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| New England Deaconess Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Washington Univ | |
| St Louis, Missouri, United States, 63108 | |
| United States, New Mexico | |
| Univ of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| SUNY / Health Sciences Ctr at Syracuse | |
| Syracuse, New York, United States, 13210 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Dayton Veterans Administration Med Ctr | |
| Dayton, Ohio, United States, 45428 | |
| Ohio State Univ / ACTU-Univ Clinic | |
| Columbus, Ohio, United States, 43210 | |
| Med College of Ohio | |
| Toledo, Ohio, United States, 43699 | |
| Univ Dermatology Associates | |
| Cincinnati, Ohio, United States, 452670523 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 972109951 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas, Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75390 | |
| Dallas Veterans Administration Med Ctr | |
| Dallas, Texas, United States, 75216 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 775550882 | |
| Scott and White Hosp | |
| Temple, Texas, United States, 76508 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 782847881 | |
| United States, Virginia | |
| Univ of Virginia Health Sciences Ctr | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Clinical Research Inc | |
| Norfolk, Virginia, United States, 23507 | |
| Salem Veterans Administration Med Ctr | |
| Salem, Virginia, United States, 24153 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Great Lakes Hemophilia Foundation | |
| Wauwatosa, Wisconsin, United States, 53213 | |
| Study Chair: | Crumpacker C |
More Information
| Study ID Numbers: | ACTG 169, Protocol -38/-022 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000953 History of Changes |
| Health Authority: | United States: Federal Government |
|
Herpes Zoster Acyclovir Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents sorivudine |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Chickenpox Infection Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Acyclovir HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections Sorivudine |