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

Primary Purpose

HIV Infections, Chickenpox

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sorivudine
Acyclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Univ of Southern California / LA County USC Med Ctr
  • UCLA Med Ctr
  • Veterans Administration Med Ctr
  • Infectious Disease Med Group
  • San Diego Naval Hosp
  • Mount Zion Med Ctr
  • Univ of Colorado Health Sciences Ctr
  • George Washington Univ Med Ctr
  • Veterans Administration Med Ctr / Community AIDS Program
  • Med College of Georgia
  • Univ of Hawaii / Leahi Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Johns Hopkins Hosp
  • Natl Institutes of Health / NIAID
  • Massachusetts Gen Hosp / Harvard Med School
  • Beth Israel Hosp
  • Brigham and Women's Hosp
  • New England Deaconess Hosp
  • Washington Univ
  • Univ of New Mexico
  • Beth Israel Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Mount Sinai Med Ctr
  • SUNY / Health Sciences Ctr at Stony Brook
  • SUNY / Health Sciences Ctr at Syracuse
  • Carolinas Med Ctr
  • Univ Dermatology Associates
  • Ohio State Univ / ACTU-Univ Clinic
  • Dayton Veterans Administration Med Ctr
  • Med College of Ohio
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Dallas Veterans Administration Med Ctr
  • Univ of Texas, Southwestern Med Ctr of Dallas
  • Univ TX Galveston Med Branch
  • Baylor College of Medicine
  • Univ TX San Antonio Health Science Ctr
  • Scott and White Hosp
  • Univ of Virginia Health Sciences Ctr
  • Virginia Clinical Research Inc
  • Salem Veterans Administration Med Ctr
  • Univ of Washington
  • Great Lakes Hemophilia Foundation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 25, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000953
Brief Title
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
Official Title
Evaluation of Brovavir ( BV-ara-U; SQ 32,756 ) Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 1996 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Chickenpox
Keywords
Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sorivudine
Intervention Type
Drug
Intervention Name(s)
Acyclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crumpacker C
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
Infectious Disease Med Group
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
San Diego Naval Hosp
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Mount Zion Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Veterans Administration Med Ctr / Community AIDS Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Univ of Hawaii / Leahi Hosp
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Natl Institutes of Health / NIAID
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Massachusetts Gen Hosp / Harvard Med School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
New England Deaconess Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington Univ
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Univ of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Univ Dermatology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670523
Country
United States
Facility Name
Ohio State Univ / ACTU-Univ Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Dayton Veterans Administration Med Ctr
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
Med College of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43699
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
972109951
Country
United States
Facility Name
Dallas Veterans Administration Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Univ of Texas, Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550882
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
782847881
Country
United States
Facility Name
Scott and White Hosp
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Univ of Virginia Health Sciences Ctr
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Clinical Research Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Salem Veterans Administration Med Ctr
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Great Lakes Hemophilia Foundation
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53213
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background

Learn more about this trial

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

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