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

Inclusion 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.