Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
NCT ID: NCT00000953
Last Updated: 2011-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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Sorivudine
Acyclovir
Eligibility Criteria
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Inclusion Criteria
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:
* Zidovudine.
* ddI.
* ddC.
Exclusion Criteria
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).
* Interferon.
* Isoprinosine.
* Levamisole.
* Transfer factor.
* Topical virucidal agents, oxidizing agents, DMSO, cell division-stimulating/healing agents, or astringents.
* Topical anesthetics (such as capsaicin or xylocaine).
* Topical creams or ointments that may interfere with evaluation of zoster lesions.
* Cimetidine.
* Fluorouracil or its derivatives, flucytosine, or cyclophosphamide (during drug administration and for 2 weeks thereafter).
* High-dose corticosteroids.
* Anticoagulant therapy (heparin locks and low-dose warfarin sodium permitted).
* Probenecid or derivatives.
* Treatment for any acute, life-threatening opportunistic infection (suppressive or prophylactic maintenance therapy other than ganciclovir or foscarnet is permitted).
Use of the following drugs is discouraged during the long-term phase of the study:
* Antiviral agents with VZV activity.
* Immunomodulators with presumed VZV activity.
* VZV immune globulin.
* Capsaicin.
* Cimetidine.
Patients with the following prior conditions are excluded:
* History of immediate hypersensitivity or serum sickness reaction or idiosyncratic reaction (such as hepatic necrosis or Stevens-Johnson syndrome) to any nucleoside analog antiviral agent or to any anticancer therapy with cytolytic agents.
Prior Medication:
Excluded within 1 month prior to entry:
* Any investigational drugs or treatments not licensed for any indication (other than ddI or ddC).
Excluded within 2 weeks prior to entry:
* Any systemic antiviral therapy, including ganciclovir, foscarnet, vidarabine, acyclovir, or ribavirin.
* Any antiretroviral drug other than zidovudine, ddI, and ddC.
* Immune globulin (e.g., IgG, VZIG).
Excluded within 72 hours prior to entry:
* Cyclophosphamide.
* Flucytosine.
* Fluorouracil or its derivatives.
Alcohol or drug abuse.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Crumpacker C
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
UCLA Med Ctr
Los Angeles, California, United States
Veterans Administration Med Ctr
Martinez, California, United States
Infectious Disease Med Group
Oakland, California, United States
San Diego Naval Hosp
San Diego, California, United States
Mount Zion Med Ctr
San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Veterans Administration Med Ctr / Community AIDS Program
Washington D.C., District of Columbia, United States
Med College of Georgia
Augusta, Georgia, United States
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Natl Institutes of Health / NIAID
Bethesda, Maryland, United States
Massachusetts Gen Hosp / Harvard Med School
Boston, Massachusetts, United States
Beth Israel Hosp
Boston, Massachusetts, United States
Brigham and Women's Hosp
Boston, Massachusetts, United States
New England Deaconess Hosp
Boston, Massachusetts, United States
Washington Univ
St Louis, Missouri, United States
Univ of New Mexico
Albuquerque, New Mexico, United States
Beth Israel Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Univ Dermatology Associates
Cincinnati, Ohio, United States
Ohio State Univ / ACTU-Univ Clinic
Columbus, Ohio, United States
Dayton Veterans Administration Med Ctr
Dayton, Ohio, United States
Med College of Ohio
Toledo, Ohio, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 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
Baylor College of Medicine
Houston, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Scott and White Hosp
Temple, Texas, United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, United States
Virginia Clinical Research Inc
Norfolk, Virginia, United States
Salem Veterans Administration Med Ctr
Salem, Virginia, United States
Univ of Washington
Seattle, Washington, United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, United States
Countries
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References
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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
Other Identifiers
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Protocol -38/-022
Identifier Type: -
Identifier Source: secondary_id
ACTG 169
Identifier Type: -
Identifier Source: org_study_id
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