Search / Trial NCT00000953

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Herpes Zoster Acyclovir Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Sorivudine

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 ...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000953_2023-12-10.pdf

4.5 MB

NCT00000953_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Houston, Texas, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Chicago, Illinois, United States

Seattle, Washington, United States

Baltimore, Maryland, United States

Charlotte, North Carolina, United States

Oakland, California, United States

New York, New York, United States

Portland, Oregon, United States

San Francisco, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Toledo, Ohio, United States

Galveston, Texas, United States

Augusta, Georgia, United States

St Louis, Missouri, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

Wauwatosa, Wisconsin, United States

Dallas, Texas, United States

Honolulu, Hawaii, United States

Martinez, California, United States

San Diego, California, United States

Washington, District Of Columbia, United States

Bethesda, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Albuquerque, New Mexico, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Temple, Texas, United States

Charlottesville, Virginia, United States

Norfolk, Virginia, United States

Salem, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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