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
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
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
Patients applied
Trial Officials
Crumpacker C
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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