Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

Glaxo Wellcome

Conditions:

HIV Infections

Chickenpox

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ...

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 i...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT00000953

Last Update

March 1 2011

Active Locations (44)

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Page 1 of 11 (44 locations)

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States, 900331079

3

UCLA Med Ctr

Los Angeles, California, United States, 90095

4

Veterans Administration Med Ctr

Martinez, California, United States, 94553