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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000953
• Other study ID #: ACTG 169
• Secondary ID: Protocol -38/-02
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: February 25, 2011

Study information

• Verified date: February 2011
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: September 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chickenpox
• HIV Infections

Intervention

Drug:
• Sorivudine

• Acyclovir

Locations

Country	Name	City	State
United States	Univ of New Mexico	Albuquerque	New Mexico
United States	Med College of Georgia	Augusta	Georgia
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Natl Institutes of Health / NIAID	Bethesda	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Hosp	Boston	Massachusetts
United States	Brigham and Women's Hosp	Boston	Massachusetts
United States	Massachusetts Gen Hosp / Harvard Med School	Boston	Massachusetts
United States	New England Deaconess Hosp	Boston	Massachusetts
United States	Carolinas Med Ctr	Charlotte	North Carolina
United States	Univ of Virginia Health Sciences Ctr	Charlottesville	Virginia
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ Dermatology Associates	Cincinnati	Ohio
United States	Ohio State Univ / ACTU-Univ Clinic	Columbus	Ohio
United States	Dallas Veterans Administration Med Ctr	Dallas	Texas
United States	Univ of Texas, Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Dayton Veterans Administration Med Ctr	Dayton	Ohio
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Univ of Hawaii / Leahi Hosp	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	UCLA Med Ctr	Los Angeles	California
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Veterans Administration Med Ctr	Martinez	California
United States	Beth Israel Med Ctr	New York	New York
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Virginia Clinical Research Inc	Norfolk	Virginia
United States	Infectious Disease Med Group	Oakland	California
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Salem Veterans Administration Med Ctr	Salem	Virginia
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	San Diego Naval Hosp	San Diego	California
United States	Mount Zion Med Ctr	San Francisco	California
United States	Univ of Washington	Seattle	Washington
United States	Washington Univ	St Louis	Missouri
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	SUNY / Health Sciences Ctr at Syracuse	Syracuse	New York
United States	Scott and White Hosp	Temple	Texas
United States	Med College of Ohio	Toledo	Ohio
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Veterans Administration Med Ctr / Community AIDS Program	Washington	District of Columbia
United States	Great Lakes Hemophilia Foundation	Wauwatosa	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Bristol-Myers Squibb, Glaxo Wellcome

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gnann J, et al. Sorivudine (BV-araU) versus acyclovir for Herpes zoster in HIV-infected patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:55

External Links

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