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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Chickenpox

Intervention: Sorivudine (Drug); Acyclovir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Crumpacker C, Study Chair

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.

Clinical Details

Official title: Evaluation of Brovavir ( BV-ara-U; SQ 32,756 ) Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients

Study design: Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 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:

- Zidovudine.

- ddI.

- ddC.

Exclusion Criteria 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).

- 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.

Locations and Contacts

Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States

UCLA Med Ctr, Los Angeles, California 90095, United States

Univ of Southern California / LA County USC Med Ctr, Los Angeles, California 900331079, 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, District of Columbia 20037, United States

Veterans Administration Med Ctr / Community AIDS Program, Washington, 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

Beth Israel Hosp, Boston, Massachusetts 02215, United States

Brigham and Women's Hosp, Boston, Massachusetts 02215, United States

Massachusetts Gen Hosp / Harvard Med School, Boston, Massachusetts 02114, 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

Mount Sinai Med Ctr, New York, New York 10029, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, 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

Additional Information

Click here for more information about Acyclovir

Related publications:

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


Last updated: February 25, 2011

Page last updated: August 23, 2015

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