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HIV InfectionsPhase 2NCT00000953

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

A Phase 2 study testing Sorivudine and Acyclovir in people with HIV Infections and Chickenpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Chickenpox
What is being tested?
Sorivudine and Acyclovir
How many people
180 participants
Where
44 sitesUnited States
Study dates
Start not givento Sep 1996
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Univ of New Mexico

    Albuquerque, New Mexico, 87131

  • Med College of Georgia

    Augusta, Georgia, 30912

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21205

  • Natl Institutes of Health / NIAID

    Bethesda, Maryland, 20892

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts Gen Hosp / Harvard Med School

    Boston, Massachusetts, 02114

  • Beth Israel Hosp

    Boston, Massachusetts, 02215

  • Brigham and Women's Hosp

    Boston, Massachusetts, 02215

  • New England Deaconess Hosp

    Boston, Massachusetts, 02215

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28204

  • Univ of Virginia Health Sciences Ctr

    Charlottesville, Virginia, 22908

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Univ Dermatology Associates

    Cincinnati, Ohio, 452670523

  • Ohio State Univ / ACTU-Univ Clinic

    Columbus, Ohio, 43210

  • Dallas Veterans Administration Med Ctr

    Dallas, Texas, 75216

  • Univ of Texas, Southwestern Med Ctr of Dallas

    Dallas, Texas, 75390

  • Dayton Veterans Administration Med Ctr

    Dayton, Ohio, 45428

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Univ TX Galveston Med Branch

    Galveston, Texas, 775550882

  • Univ of Hawaii / Leahi Hosp

    Honolulu, Hawaii, 96816

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • UCLA Med Ctr

    Los Angeles, California, 90095

  • Veterans Administration Med Ctr

    Martinez, California, 94553

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Mem Sloan - Kettering Cancer Ctr

    New York, New York, 10021

  • Saint Luke's - Roosevelt Hosp Ctr

    New York, New York, 10025

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Virginia Clinical Research Inc

    Norfolk, Virginia, 23507

  • Infectious Disease Med Group

    Oakland, California, 94609

  • Portland Veterans Adm Med Ctr / Rsch & Education Grp

    Portland, Oregon, 972109951

  • Salem Veterans Administration Med Ctr

    Salem, Virginia, 24153

  • Univ TX San Antonio Health Science Ctr

    San Antonio, Texas, 782847881

  • San Diego Naval Hosp

    San Diego, California, 92134

  • Mount Zion Med Ctr

    San Francisco, California, 94115

  • Univ of Washington

    Seattle, Washington, 98104

  • Washington Univ

    St Louis, Missouri, 63108

  • SUNY / Health Sciences Ctr at Stony Brook

    Stony Brook, New York, 11794

  • SUNY / Health Sciences Ctr at Syracuse

    Syracuse, New York, 13210

  • Scott and White Hosp

    Temple, Texas, 76508

  • Med College of Ohio

    Toledo, Ohio, 43699

  • George Washington Univ Med Ctr

    Washington D.C., District of Columbia, 20037

  • Veterans Administration Med Ctr / Community AIDS Program

    Washington D.C., District of Columbia, 20422

  • Great Lakes Hemophilia Foundation

    Wauwatosa, Wisconsin, 53213

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Sorivudine, Acyclovir
Keywords
Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine
Medical subject headings
HIV Infections, Chickenpox, Herpes Zoster, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorivudineDrug

  • AcyclovirDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Primary completionSep 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
180 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000953
Sponsor's protocol ID
ACTG 169
Other IDs
Protocol -38/-022
Status last verified
Feb 2011
First submitted
2 Nov 1999
Last updated
1 Mar 2011
Results posted
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorivudine and Acyclovir in people with HIV Infections and Chickenpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2011.

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