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


Phase 2
18 Years
N/A
Not Enrolling
Both
HIV Infections, Chickenpox

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Trial Information

Evaluation of Brovavir ( BV-ara-U; SQ 32,756 ) Versus Acyclovir in 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.

One hundred-eighty patients are randomized to receive either brovavir or acyclovir as
follows: brovavir or its matching placebo once daily and acyclovir or its matching placebo
five times daily. Treatment continues for 10 days. Entry into the study must occur within 72
hours of lesion development. Patients are followed in person daily or at regular intervals
during study drug administration and on days 14, 21, and 28, and then monthly by telephone
for 11 months thereafter.

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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Crumpacker C

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 169

NCT ID:

NCT00000953

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Chickenpox
  • Herpes Zoster
  • Acyclovir
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • sorivudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Chickenpox
  • Herpes Zoster

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
George Washington Univ Med CtrWashington, District of Columbia  20037
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Mount Sinai Med CtrNew York, New York  10029
Med College of OhioToledo, Ohio  43699
Univ of WashingtonSeattle, Washington  98105
Great Lakes Hemophilia FoundationMilwaukee, Wisconsin  53233
Johns Hopkins HospBaltimore, Maryland  21287
Univ TX Galveston Med BranchGalveston, Texas  77550
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Beth Israel Med CtrNew York, New York  10003
Carolinas Med CtrCharlotte, North Carolina  28203
Portland Veterans Adm Med Ctr / Rsch & Education GrpPortland, Oregon  972109951
Univ of Texas, Southwestern Med Ctr of DallasDallas, Texas  75390
UCLA Med CtrLos Angeles, California  90095
Veterans Administration Med CtrMartinez, California  94553
Infectious Disease Med GroupOakland, California  94609
San Diego Naval HospSan Diego, California  92134
Mount Zion Med CtrSan Francisco, California  94115
Veterans Administration Med Ctr / Community AIDS ProgramWashington, District of Columbia  20422
Med College of GeorgiaAugusta, Georgia  30912
Univ of Hawaii / Leahi HospHonolulu, Hawaii  96816
Natl Institutes of Health / NIAIDBethesda, Maryland  20892
Massachusetts Gen Hosp / Harvard Med SchoolBoston, Massachusetts  02114
Brigham and Women's HospBoston, Massachusetts  02215
Beth Israel HospBoston, Massachusetts  02215
New England Deaconess HospBoston, Massachusetts  02215
Washington UnivSt Louis, Missouri  63108
Univ of New MexicoAlbuquerque, New Mexico  87131
SUNY / Health Sciences Ctr at Stony BrookStony Brook, New York  11794
SUNY / Health Sciences Ctr at SyracuseSyracuse, New York  13210
Univ Dermatology AssociatesCincinnati, Ohio  452670523
Ohio State Univ / ACTU-Univ ClinicColumbus, Ohio  43210
Dayton Veterans Administration Med CtrDayton, Ohio  45428
Dallas Veterans Administration Med CtrDallas, Texas  75216
Baylor College of MedicineHouston, Texas  77030
Univ TX San Antonio Health Science CtrSan Antonio, Texas  782847881
Scott and White HospTemple, Texas  76508
Univ of Virginia Health Sciences CtrCharlottesville, Virginia  22908
Virginia Clinical Research IncNorfolk, Virginia  23507
Salem Veterans Administration Med CtrSalem, Virginia  24153