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

Completed · Phase 2

Conditions studied: HIV Infections, Chickenpox

In brief

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.

Key facts

Study ID

NCT00000953

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

180

Last updated by the study team

2011-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Zidovudine.
• ddI.
• ddC.

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).
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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