Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
Evaluation of Brovavir ( BV-ara-U; SQ 32,756 ) Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients
2 other identifiers
interventional
180
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
September 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 1, 2011
February 1, 2011
November 2, 1999
February 25, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Medication for concurrent conditions (e.g., insulin, antihypertensives, bronchodilators, digoxin) or antibacterials or antifungals to treat concurrent infections at other sites or superinfection of the zoster lesion.
- Anti-inflammatory, analgesic (including narcotic analgesic), or antipyretic agents.
- Antidepressants and antipsychotics such as amitriptyline and/or fluphenazine.
- Nerve blocks.
- AZT, ddI, ddC, and amantadine.
- Low-dose corticosteroids for treatment of an underlying (not zoster-related) disease.
- Immune modulators without varicella-zoster virus activity (e.g., GM-CSF, gp160 vaccine).
- Patients must have:
- HIV infection.
- Localized, cutaneous herpes zoster (shingles).
- Zoster-associated rash present for 3 or fewer days prior to entry.
- Prior Medication:
- Allowed:
- +3 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Chickenpox.
- Evidence of visceral dissemination (organ involvement, i.e., brain, liver, or lung) and/or cutaneous dissemination (more than 20 vesicles in dermatomes beyond contiguous dermatomes) of zoster.
- Zoster-like lesion caused by organism other than VZV (e.g., HSV, enterovirus, or Mycoplasma).
- Bacterial superinfection of zoster lesion.
- Zosteriform lesion previously treated with topical antiviral agents.
- Acute, life-threatening opportunistic infection requiring treatment (ongoing suppressive or prophylactic maintenance therapy other than ganciclovir or foscarnet is permitted).
- Concurrent severe disease that may either impair ability to take oral medication in capsule or tablet form or limit survival during the 10-day treatment period or during acute phase follow-up (28 days).
- Suspected acute deterioration of renal or hepatic function.
- Mental impairment that precludes ability to comply with protocol.
- Any condition that would render the patient unsuitable for treatment.
- Concurrent Medication:
- Excluded during acute phase of study:
- Antiviral medications other than AZT, ddI, ddC, or anti-Parkinson's drugs (i.e., amantadine).
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Bristol-Myers Squibbcollaborator
- Glaxo Wellcomecollaborator
Study Sites (44)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA Med Ctr
Los Angeles, California, 90095, United States
Veterans Administration Med Ctr
Martinez, California, 94553, United States
Infectious Disease Med Group
Oakland, California, 94609, United States
San Diego Naval Hosp
San Diego, California, 92134, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Veterans Administration Med Ctr / Community AIDS Program
Washington D.C., District of Columbia, 20422, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, 96816, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Natl Institutes of Health / NIAID
Bethesda, Maryland, 20892, United States
Massachusetts Gen Hosp / Harvard Med School
Boston, Massachusetts, 02114, United States
Beth Israel Hosp
Boston, Massachusetts, 02215, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215, United States
New England Deaconess Hosp
Boston, Massachusetts, 02215, United States
Washington Univ
St Louis, Missouri, 63108, United States
Univ of New Mexico
Albuquerque, New Mexico, 87131, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 11794, United States
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, 13210, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28204, United States
Univ Dermatology Associates
Cincinnati, Ohio, 452670523, United States
Ohio State Univ / ACTU-Univ Clinic
Columbus, Ohio, 43210, United States
Dayton Veterans Administration Med Ctr
Dayton, Ohio, 45428, United States
Med College of Ohio
Toledo, Ohio, 43699, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951, United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881, United States
Scott and White Hosp
Temple, Texas, 76508, United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908, United States
Virginia Clinical Research Inc
Norfolk, Virginia, 23507, United States
Salem Veterans Administration Med Ctr
Salem, Virginia, 24153, United States
Univ of Washington
Seattle, Washington, 98104, United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 53213, United States
Related Publications (1)
Gnann J, et al. Sorivudine (BV-araU) versus acyclovir for Herpes zoster in HIV-infected patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:55
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Crumpacker C
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
September 1, 1996
Last Updated
March 1, 2011
Record last verified: 2011-02